Latest Pharma Insights
Abbott To Spin Off Nutrition, Leaving A Diagnostics And Devices Core As Formula Suits Linger
Abbott is spinning off its $8.5bn nutrition business in 2027 with roughly 1,700 infant-formula lawsuits still pending — and CEO Robert Ford has yet to say whether that legal exposure stays with Abbott or goes with the new company.
HBW Insight - October 22, 2026
Abbott is spinning off its $8.5bn nutrition business in 2027 with roughly 1,700 infant-formula lawsuits still pending — and CEO Robert Ford has yet to say whether that legal exposure stays with Abbott or goes with the new company.
HBW Insight - October 22, 2026
FDA’s New PCCP Pages Add Case Studies, Instructions And A 240-Device List
A new FDA website on predetermined change control plans lists the 240 devices authorized with them so far, led by Medtronic and MiniMed, and adds two hypothetical software case studies.
Medtech Insight - October 22, 2026
A new FDA website on predetermined change control plans lists the 240 devices authorized with them so far, led by Medtronic and MiniMed, and adds two hypothetical software case studies.
Medtech Insight - October 22, 2026
Second Swing For Lumineux ’30 Minutes To Whiter Teeth’ Claim’ Showed Results Too Good To Be True
NAD found “fatal flaws” in three studies Oral Essentials submitted in second review of “30 minutes to whiter teeth” claim it had considered in 2023 review which also found the firm didn’t support superiority claims challenged by Crest 3D White Whitestrips marketer P&G.
HBW Insight - October 22, 2026
NAD found “fatal flaws” in three studies Oral Essentials submitted in second review of “30 minutes to whiter teeth” claim it had considered in 2023 review which also found the firm didn’t support superiority claims challenged by Crest 3D White Whitestrips marketer P&G.
HBW Insight - October 22, 2026
Merck/Moderna Hit By Intismeran ESMO Leak, But Data Support Investment Hypotheses
Leaked results slated for presentation at ESMO prompted debate about the neoantigen therapy’s applicability in other tumors and pushed both companies’ share prices lower, but the data impressed analysts.
Scrip - October 22, 2026
Leaked results slated for presentation at ESMO prompted debate about the neoantigen therapy’s applicability in other tumors and pushed both companies’ share prices lower, but the data impressed analysts.
Scrip - October 22, 2026
Biohaven’s Troriluzole Gets Another Chance At US FDA
Following a refuse-to-file letter and a complete response letter, Biohaven’s drug will be reviewed by the FDA for approval in spinocerebellar ataxia, with an early 2027 action date and plans for an advisory committee.
Scrip - October 22, 2026
Following a refuse-to-file letter and a complete response letter, Biohaven’s drug will be reviewed by the FDA for approval in spinocerebellar ataxia, with an early 2027 action date and plans for an advisory committee.
Scrip - October 22, 2026
EU Parliament Reportedly Clears Omnibus VI; US FDA Finalizes Cosmetic Recall Guidance
The European Parliament has approved the Omnibus VI package, says the EFfCI, as the US FDA has finalized its mandatory cosmetic recall guidance under MoCRA.
HBW Insight - October 22, 2026
The European Parliament has approved the Omnibus VI package, says the EFfCI, as the US FDA has finalized its mandatory cosmetic recall guidance under MoCRA.
HBW Insight - October 22, 2026
Drug Manufacturers Push US Launch Prices, Despite MFN
New drugs are hitting the US market with staggering six-digit price tags, even as scrutiny on US drug prices versus prices in other countries has intensified under President Trump’s most favored nation strategy.
Scrip - October 22, 2026
New drugs are hitting the US market with staggering six-digit price tags, even as scrutiny on US drug prices versus prices in other countries has intensified under President Trump’s most favored nation strategy.
Scrip - October 22, 2026
Tarver: CDRH Rebuilding Review Staff As Novel Device Authorizations Reach 151 In Fiscal 2026
Speaking at the MedTech Conference in Boston, CDRH director Michelle Tarver said the center authorized 151 novel devices in FY 2026 and is rebuilding a workforce that lost around 30% of its reviewers. She said the proposed MDUFA VI agreement is targeted for submission to Congress by January 2027.
Medtech Insight - October 22, 2026
Speaking at the MedTech Conference in Boston, CDRH director Michelle Tarver said the center authorized 151 novel devices in FY 2026 and is rebuilding a workforce that lost around 30% of its reviewers. She said the proposed MDUFA VI agreement is targeted for submission to Congress by January 2027.
Medtech Insight - October 22, 2026
AbbVie Poised To Bring Novel Mechanism To Hidradenitis Suppurativa
A Phase III trial testing the IL-1?/1? antagonist lutikizumab in HS met the primary endpoint, but the placebo-adjusted response rate raises questions about the profile versus competitors.
Scrip - October 22, 2026
A Phase III trial testing the IL-1?/1? antagonist lutikizumab in HS met the primary endpoint, but the placebo-adjusted response rate raises questions about the profile versus competitors.
Scrip - October 22, 2026
Finance Watch: Clinical Trial Setbacks And Strategic Shifts Lead To Job Cuts
Restructuring Edition: EyePoint announced a Phase III trial failure and a 53% headcount reduction, Enlivex ended preclinical development and laid off 60% of its employees, Caribou cut jobs as it began a review of strategic alternatives and private Adecto shut down.
Scrip - October 22, 2026
Restructuring Edition: EyePoint announced a Phase III trial failure and a 53% headcount reduction, Enlivex ended preclinical development and laid off 60% of its employees, Caribou cut jobs as it began a review of strategic alternatives and private Adecto shut down.
Scrip - October 22, 2026
Ipsen Chief Heralds Blockbuster Potential Of Pipeline
CEO David Loew has told analysts that the French firm has "a focused pipeline with multiple opportunities capable of becoming meaningful new medicines."
Scrip - October 22, 2026
CEO David Loew has told analysts that the French firm has "a focused pipeline with multiple opportunities capable of becoming meaningful new medicines."
Scrip - October 22, 2026
Scrip Awards Podcast – Parabilis CEO Mathai Mammen Interview
As a curtain-raiser to the awards in December, we talk to Parabilis, which achieved a record-breaking IPO and is a shortlisted finalist for Biotech Company of the Year.
Scrip - October 22, 2026
As a curtain-raiser to the awards in December, we talk to Parabilis, which achieved a record-breaking IPO and is a shortlisted finalist for Biotech Company of the Year.
Scrip - October 22, 2026
UK Pathology Looks To Carter 2026 Review For Momentum Towards IVDs Tariff
UK pathology is in the spotlight in the wake of the Pathology Transformation Review 2026. Ravi Chana, head of diagnostics at the ABHI industry association, said the opportunity for payment reform, improved IVDs adoption and system-wide savings should not be spurned.
Medtech Insight - October 22, 2026
UK pathology is in the spotlight in the wake of the Pathology Transformation Review 2026. Ravi Chana, head of diagnostics at the ABHI industry association, said the opportunity for payment reform, improved IVDs adoption and system-wide savings should not be spurned.
Medtech Insight - October 22, 2026
US FDA Drops CIO, But Keeps Sanjay Sahoo As Acting Head Of New Mission IT Office
The FDA retired the Chief Information Officer title, but Sanjay Sahoo moved to temporarily lead the new Office of Mission Information Technology Services as the agency’s technology push shifts to Jared Seehafer, deputy commissioner for technology and artificial intelligence.
Medtech Insight - October 22, 2026
The FDA retired the Chief Information Officer title, but Sanjay Sahoo moved to temporarily lead the new Office of Mission Information Technology Services as the agency’s technology push shifts to Jared Seehafer, deputy commissioner for technology and artificial intelligence.
Medtech Insight - October 22, 2026
EU Urged To Follow US Lead On Rx-To-OTC Switch Exclusivity
AESGP wants EU data protection for switch evidence extended to three years and has presented eight recommendations to simplify switch pathways. The call comes as naloxone spray Nyxoid is poised to become only the seventh active substance switched through the EU's centralised route.
HBW Insight - October 22, 2026
AESGP wants EU data protection for switch evidence extended to three years and has presented eight recommendations to simplify switch pathways. The call comes as naloxone spray Nyxoid is poised to become only the seventh active substance switched through the EU's centralised route.
HBW Insight - October 22, 2026
AstraZeneca Adds IgAN To Blockbuster Ultomiris With Accelerated Approval
AstraZeneca says data from the Phase III I CAN trial are intended to support traditional approval for Ultomiris in IgAN.
Scrip - October 22, 2026
AstraZeneca says data from the Phase III I CAN trial are intended to support traditional approval for Ultomiris in IgAN.
Scrip - October 22, 2026
NRx Looks To Pin Down Name For Preservative-Free Ketamine Ahead Of FDA Goal Date
NRx Pharmaceuticals has received a discipline review letter from the US Food and Drug Administration requesting "minor” changes to the submitted label for its preservative-free ketamine ahead of its Nov. 10 GDUFA goal date, including the product’s proprietary name that is currently under review.
Generics Bulletin - October 22, 2026
NRx Pharmaceuticals has received a discipline review letter from the US Food and Drug Administration requesting "minor” changes to the submitted label for its preservative-free ketamine ahead of its Nov. 10 GDUFA goal date, including the product’s proprietary name that is currently under review.
Generics Bulletin - October 22, 2026
Alvotech To Double Humira Biosimilar Output With New Process Approval From US FDA
FDA approval of a new adalimumab manufacturing process and a second drug substance suite in Reykjavik will more than double Alvotech's Simlandi batch output while freeing capacity for its broader biosimilar portfolio.
Generics Bulletin - October 22, 2026
FDA approval of a new adalimumab manufacturing process and a second drug substance suite in Reykjavik will more than double Alvotech's Simlandi batch output while freeing capacity for its broader biosimilar portfolio.
Generics Bulletin - October 22, 2026
Par Issues A Trio Of Recalls After FDA Warning Letter
Par Health has issued three US recall notices for injectables within a month of each other due to the presence of particulate matter. The recalls form part of remediation efforts for its site in Rochester, Michigan following receipt of an FDA warning letter in April 2026.
Generics Bulletin - October 22, 2026
Par Health has issued three US recall notices for injectables within a month of each other due to the presence of particulate matter. The recalls form part of remediation efforts for its site in Rochester, Michigan following receipt of an FDA warning letter in April 2026.
Generics Bulletin - October 22, 2026
Roche Looks To Breast Cancer And MS Approvals To Boost 2027
The Swiss pharma company is banking on imminent approvals for giredestrant and fenebrutinib to reignite investor excitement.
Scrip - October 22, 2026
The Swiss pharma company is banking on imminent approvals for giredestrant and fenebrutinib to reignite investor excitement.
Scrip - October 22, 2026
NVIDIA Partnership Fuels Danaher’s ‘Autonomous Science’ Push As It Exceeds Q3 Expectations
Danaher says it wants to foster more connections between its operating companies across diagnostics and life sciences.
Medtech Insight - October 22, 2026
Danaher says it wants to foster more connections between its operating companies across diagnostics and life sciences.
Medtech Insight - October 22, 2026
CAR-T’s $12bn Future Hinges On More Than New Approvals
CAR-T sales are forecast to nearly double by 2032 but sustaining that growth will hinge on earlier-line adoption, next-gen platforms and the ability to overcome mounting competition and access barriers.
In Vivo - October 22, 2026
CAR-T sales are forecast to nearly double by 2032 but sustaining that growth will hinge on earlier-line adoption, next-gen platforms and the ability to overcome mounting competition and access barriers.
In Vivo - October 22, 2026
BioJapan: Japan Bioclusters Build Global Partnerships To Enhance Expertise
One of Japan's largest bioclusters, Shonan iPark, announces a new partnership with J&J focused on discovery and incubation of domestic science, while the National Cancer Center Japan elaborates how its ties with Texas Medical Center have helped startups spread their wings.
Scrip - October 22, 2026
One of Japan's largest bioclusters, Shonan iPark, announces a new partnership with J&J focused on discovery and incubation of domestic science, while the National Cancer Center Japan elaborates how its ties with Texas Medical Center have helped startups spread their wings.
Scrip - October 22, 2026
Page Error Or Postponement? Commission Says No 2026 Consultation Planned On EU Supplement Limits
Exclusive: The EC says no consultation on EU supplement vitamin and mineral limits is planned for 2026, calling its Q3 listing an error. FoodChain ID’s Jérôme Le Bloch says the delay may give the EC time to finalize a more refined proposal, but should not shorten stakeholders’ window to comment.
HBW Insight - October 22, 2026
Exclusive: The EC says no consultation on EU supplement vitamin and mineral limits is planned for 2026, calling its Q3 listing an error. FoodChain ID’s Jérôme Le Bloch says the delay may give the EC time to finalize a more refined proposal, but should not shorten stakeholders’ window to comment.
HBW Insight - October 22, 2026
7 Major Changes MHRA Promises For 2030, As It Navigates Increasing EU Uncertainty
The MHRA’s 2030 Strategy promises a regulator that is more responsive, more proportionate and more international – but industry bodies want more details.
In Vivo - October 22, 2026
The MHRA’s 2030 Strategy promises a regulator that is more responsive, more proportionate and more international – but industry bodies want more details.
In Vivo - October 22, 2026
Thermo Fisher Raises 2026 Outlook Amid Stronger Pharma Demand, But Diagnostics Holds Flat
Thermo Fisher raised its 2026 revenue and EPS outlook as pharma and biotech demand lifted Q3 organic growth to 6%, though tariff refunds supplied more than half of the EPS beat. Specialty Diagnostics was flat organically after the microbiology sale.
Medtech Insight - October 22, 2026
Thermo Fisher raised its 2026 revenue and EPS outlook as pharma and biotech demand lifted Q3 organic growth to 6%, though tariff refunds supplied more than half of the EPS beat. Specialty Diagnostics was flat organically after the microbiology sale.
Medtech Insight - October 22, 2026
Abbott To Spin Off Nutrition, Leaving A Diagnostics And Devices Core As Formula Suits Linger
Abbott is spinning off its $8.5bn nutrition business in 2027 with roughly 1,700 infant-formula lawsuits still pending — and CEO Robert Ford has yet to say whether that legal exposure stays with Abbott or goes with the new company.
Medtech Insight - October 22, 2026
Abbott is spinning off its $8.5bn nutrition business in 2027 with roughly 1,700 infant-formula lawsuits still pending — and CEO Robert Ford has yet to say whether that legal exposure stays with Abbott or goes with the new company.
Medtech Insight - October 22, 2026
GLP-1s Key Factor In Changes To Nutritional Needs Supplement Firms Should Meet – NIH Official
NIH nutrition research and dietary supplement chief Andrew Bremer says providing nutritionals for consumers receiving drug treatments, such as GLP-1 patients, or who have conditions causing low nutrition levels is “extraordinary opportunity” for supplement industry.
HBW Insight - October 22, 2026
NIH nutrition research and dietary supplement chief Andrew Bremer says providing nutritionals for consumers receiving drug treatments, such as GLP-1 patients, or who have conditions causing low nutrition levels is “extraordinary opportunity” for supplement industry.
HBW Insight - October 22, 2026
AI Chatbots Are Fielding Beauty Shoppers’ Questions. Brands May Be Responsible For Answers
In an Oct. 20 interview, NAD attorney Laura Protzmann said a beauty brand’s exposure for what a chatbot says turns on how much control it has, and warned that the line may blur as brands work to shape the information third-party chatbots relay.
HBW Insight - October 22, 2026
In an Oct. 20 interview, NAD attorney Laura Protzmann said a beauty brand’s exposure for what a chatbot says turns on how much control it has, and warned that the line may blur as brands work to shape the information third-party chatbots relay.
HBW Insight - October 22, 2026
Merck/Moderna Hit By Intismeran ESMO Leak, But Data Support Investment Hypotheses
Leaked results slated for presentation at ESMO prompted debate about the neoantigen therapy’s applicability in other tumors and pushed both companies’ share prices lower, but the data impressed analysts.
Scrip - October 22, 2026
Leaked results slated for presentation at ESMO prompted debate about the neoantigen therapy’s applicability in other tumors and pushed both companies’ share prices lower, but the data impressed analysts.
Scrip - October 22, 2026
Biohaven’s Troriluzole Gets Another Chance At US FDA
Following a refuse-to-file letter and a complete response letter, Biohaven’s drug will be reviewed by the FDA for approval in spinocerebellar ataxia, with an early 2027 action date and plans for an advisory committee.
Scrip - October 22, 2026
Following a refuse-to-file letter and a complete response letter, Biohaven’s drug will be reviewed by the FDA for approval in spinocerebellar ataxia, with an early 2027 action date and plans for an advisory committee.
Scrip - October 22, 2026
Drug Manufacturers Push US Launch Prices, Despite MFN
New drugs are hitting the US market with staggering six-digit price tags, even as scrutiny on US drug prices versus prices in other countries has intensified under President Trump’s most favored nation strategy.
Scrip - October 22, 2026
New drugs are hitting the US market with staggering six-digit price tags, even as scrutiny on US drug prices versus prices in other countries has intensified under President Trump’s most favored nation strategy.
Scrip - October 22, 2026
AbbVie Poised To Bring Novel Mechanism To Hidradenitis Suppurativa
A Phase III trial testing the IL-1?/1? antagonist lutikizumab in HS met the primary endpoint, but the placebo-adjusted response rate raises questions about the profile versus competitors.
Scrip - October 22, 2026
A Phase III trial testing the IL-1?/1? antagonist lutikizumab in HS met the primary endpoint, but the placebo-adjusted response rate raises questions about the profile versus competitors.
Scrip - October 22, 2026
Finance Watch: Clinical Trial Setbacks And Strategic Shifts Lead To Job Cuts
Restructuring Edition: EyePoint announced a Phase III trial failure and a 53% headcount reduction, Enlivex ended preclinical development and laid off 60% of its employees, Caribou cut jobs as it began a review of strategic alternatives and private Adecto shut down.
Scrip - October 22, 2026
Restructuring Edition: EyePoint announced a Phase III trial failure and a 53% headcount reduction, Enlivex ended preclinical development and laid off 60% of its employees, Caribou cut jobs as it began a review of strategic alternatives and private Adecto shut down.
Scrip - October 22, 2026
Ipsen Chief Heralds Blockbuster Potential Of Pipeline
CEO David Loew has told analysts that the French firm has "a focused pipeline with multiple opportunities capable of becoming meaningful new medicines."
Scrip - October 22, 2026
CEO David Loew has told analysts that the French firm has "a focused pipeline with multiple opportunities capable of becoming meaningful new medicines."
Scrip - October 22, 2026
Scrip Awards Podcast – Parabilis CEO Mathai Mammen Interview
As a curtain-raiser to the awards in December, we talk to Parabilis, which achieved a record-breaking IPO and is a shortlisted finalist for Biotech Company of the Year.
Scrip - October 22, 2026
As a curtain-raiser to the awards in December, we talk to Parabilis, which achieved a record-breaking IPO and is a shortlisted finalist for Biotech Company of the Year.
Scrip - October 22, 2026
AstraZeneca Adds IgAN To Blockbuster Ultomiris With Accelerated Approval
AstraZeneca says data from the Phase III I CAN trial are intended to support traditional approval for Ultomiris in IgAN.
Scrip - October 22, 2026
AstraZeneca says data from the Phase III I CAN trial are intended to support traditional approval for Ultomiris in IgAN.
Scrip - October 22, 2026
Roche Looks To Breast Cancer And MS Approvals To Boost 2027
The Swiss pharma company is banking on imminent approvals for giredestrant and fenebrutinib to reignite investor excitement.
Scrip - October 22, 2026
The Swiss pharma company is banking on imminent approvals for giredestrant and fenebrutinib to reignite investor excitement.
Scrip - October 22, 2026
BioJapan: Japan Bioclusters Build Global Partnerships To Enhance Expertise
One of Japan's largest bioclusters, Shonan iPark, announces a new partnership with J&J focused on discovery and incubation of domestic science, while the National Cancer Center Japan elaborates how its ties with Texas Medical Center have helped startups spread their wings.
Scrip - October 22, 2026
One of Japan's largest bioclusters, Shonan iPark, announces a new partnership with J&J focused on discovery and incubation of domestic science, while the National Cancer Center Japan elaborates how its ties with Texas Medical Center have helped startups spread their wings.
Scrip - October 22, 2026
FDA’s New PCCP Pages Add Case Studies, Instructions And A 240-Device List
A new FDA website on predetermined change control plans lists the 240 devices authorized with them so far, led by Medtronic and MiniMed, and adds two hypothetical software case studies.
Medtech Insight - October 22, 2026
A new FDA website on predetermined change control plans lists the 240 devices authorized with them so far, led by Medtronic and MiniMed, and adds two hypothetical software case studies.
Medtech Insight - October 22, 2026
Tarver: CDRH Rebuilding Review Staff As Novel Device Authorizations Reach 151 In Fiscal 2026
Speaking at the MedTech Conference in Boston, CDRH director Michelle Tarver said the center authorized 151 novel devices in FY 2026 and is rebuilding a workforce that lost around 30% of its reviewers. She said the proposed MDUFA VI agreement is targeted for submission to Congress by January 2027.
Medtech Insight - October 22, 2026
Speaking at the MedTech Conference in Boston, CDRH director Michelle Tarver said the center authorized 151 novel devices in FY 2026 and is rebuilding a workforce that lost around 30% of its reviewers. She said the proposed MDUFA VI agreement is targeted for submission to Congress by January 2027.
Medtech Insight - October 22, 2026
UK Pathology Looks To Carter 2026 Review For Momentum Towards IVDs Tariff
UK pathology is in the spotlight in the wake of the Pathology Transformation Review 2026. Ravi Chana, head of diagnostics at the ABHI industry association, said the opportunity for payment reform, improved IVDs adoption and system-wide savings should not be spurned.
Medtech Insight - October 22, 2026
UK pathology is in the spotlight in the wake of the Pathology Transformation Review 2026. Ravi Chana, head of diagnostics at the ABHI industry association, said the opportunity for payment reform, improved IVDs adoption and system-wide savings should not be spurned.
Medtech Insight - October 22, 2026
US FDA Drops CIO, But Keeps Sanjay Sahoo As Acting Head Of New Mission IT Office
The FDA retired the Chief Information Officer title, but Sanjay Sahoo moved to temporarily lead the new Office of Mission Information Technology Services as the agency’s technology push shifts to Jared Seehafer, deputy commissioner for technology and artificial intelligence.
Medtech Insight - October 22, 2026
The FDA retired the Chief Information Officer title, but Sanjay Sahoo moved to temporarily lead the new Office of Mission Information Technology Services as the agency’s technology push shifts to Jared Seehafer, deputy commissioner for technology and artificial intelligence.
Medtech Insight - October 22, 2026
NVIDIA Partnership Fuels Danaher’s ‘Autonomous Science’ Push As It Exceeds Q3 Expectations
Danaher says it wants to foster more connections between its operating companies across diagnostics and life sciences.
Medtech Insight - October 22, 2026
Danaher says it wants to foster more connections between its operating companies across diagnostics and life sciences.
Medtech Insight - October 22, 2026
Thermo Fisher Raises 2026 Outlook Amid Stronger Pharma Demand, But Diagnostics Holds Flat
Thermo Fisher raised its 2026 revenue and EPS outlook as pharma and biotech demand lifted Q3 organic growth to 6%, though tariff refunds supplied more than half of the EPS beat. Specialty Diagnostics was flat organically after the microbiology sale.
Medtech Insight - October 22, 2026
Thermo Fisher raised its 2026 revenue and EPS outlook as pharma and biotech demand lifted Q3 organic growth to 6%, though tariff refunds supplied more than half of the EPS beat. Specialty Diagnostics was flat organically after the microbiology sale.
Medtech Insight - October 22, 2026
Abbott To Spin Off Nutrition, Leaving A Diagnostics And Devices Core As Formula Suits Linger
Abbott is spinning off its $8.5bn nutrition business in 2027 with roughly 1,700 infant-formula lawsuits still pending — and CEO Robert Ford has yet to say whether that legal exposure stays with Abbott or goes with the new company.
Medtech Insight - October 22, 2026
Abbott is spinning off its $8.5bn nutrition business in 2027 with roughly 1,700 infant-formula lawsuits still pending — and CEO Robert Ford has yet to say whether that legal exposure stays with Abbott or goes with the new company.
Medtech Insight - October 22, 2026
Abbott To Spin Off Nutrition, Leaving A Diagnostics And Devices Core As Formula Suits Linger
Abbott is spinning off its $8.5bn nutrition business in 2027 with roughly 1,700 infant-formula lawsuits still pending — and CEO Robert Ford has yet to say whether that legal exposure stays with Abbott or goes with the new company.
HBW Insight - October 22, 2026
Abbott is spinning off its $8.5bn nutrition business in 2027 with roughly 1,700 infant-formula lawsuits still pending — and CEO Robert Ford has yet to say whether that legal exposure stays with Abbott or goes with the new company.
HBW Insight - October 22, 2026
Second Swing For Lumineux ’30 Minutes To Whiter Teeth’ Claim’ Showed Results Too Good To Be True
NAD found “fatal flaws” in three studies Oral Essentials submitted in second review of “30 minutes to whiter teeth” claim it had considered in 2023 review which also found the firm didn’t support superiority claims challenged by Crest 3D White Whitestrips marketer P&G.
HBW Insight - October 22, 2026
NAD found “fatal flaws” in three studies Oral Essentials submitted in second review of “30 minutes to whiter teeth” claim it had considered in 2023 review which also found the firm didn’t support superiority claims challenged by Crest 3D White Whitestrips marketer P&G.
HBW Insight - October 22, 2026
EU Parliament Reportedly Clears Omnibus VI; US FDA Finalizes Cosmetic Recall Guidance
The European Parliament has approved the Omnibus VI package, says the EFfCI, as the US FDA has finalized its mandatory cosmetic recall guidance under MoCRA.
HBW Insight - October 22, 2026
The European Parliament has approved the Omnibus VI package, says the EFfCI, as the US FDA has finalized its mandatory cosmetic recall guidance under MoCRA.
HBW Insight - October 22, 2026
EU Urged To Follow US Lead On Rx-To-OTC Switch Exclusivity
AESGP wants EU data protection for switch evidence extended to three years and has presented eight recommendations to simplify switch pathways. The call comes as naloxone spray Nyxoid is poised to become only the seventh active substance switched through the EU's centralised route.
HBW Insight - October 22, 2026
AESGP wants EU data protection for switch evidence extended to three years and has presented eight recommendations to simplify switch pathways. The call comes as naloxone spray Nyxoid is poised to become only the seventh active substance switched through the EU's centralised route.
HBW Insight - October 22, 2026
Page Error Or Postponement? Commission Says No 2026 Consultation Planned On EU Supplement Limits
Exclusive: The EC says no consultation on EU supplement vitamin and mineral limits is planned for 2026, calling its Q3 listing an error. FoodChain ID’s Jérôme Le Bloch says the delay may give the EC time to finalize a more refined proposal, but should not shorten stakeholders’ window to comment.
HBW Insight - October 22, 2026
Exclusive: The EC says no consultation on EU supplement vitamin and mineral limits is planned for 2026, calling its Q3 listing an error. FoodChain ID’s Jérôme Le Bloch says the delay may give the EC time to finalize a more refined proposal, but should not shorten stakeholders’ window to comment.
HBW Insight - October 22, 2026
GLP-1s Key Factor In Changes To Nutritional Needs Supplement Firms Should Meet – NIH Official
NIH nutrition research and dietary supplement chief Andrew Bremer says providing nutritionals for consumers receiving drug treatments, such as GLP-1 patients, or who have conditions causing low nutrition levels is “extraordinary opportunity” for supplement industry.
HBW Insight - October 22, 2026
NIH nutrition research and dietary supplement chief Andrew Bremer says providing nutritionals for consumers receiving drug treatments, such as GLP-1 patients, or who have conditions causing low nutrition levels is “extraordinary opportunity” for supplement industry.
HBW Insight - October 22, 2026
AI Chatbots Are Fielding Beauty Shoppers’ Questions. Brands May Be Responsible For Answers
In an Oct. 20 interview, NAD attorney Laura Protzmann said a beauty brand’s exposure for what a chatbot says turns on how much control it has, and warned that the line may blur as brands work to shape the information third-party chatbots relay.
HBW Insight - October 22, 2026
In an Oct. 20 interview, NAD attorney Laura Protzmann said a beauty brand’s exposure for what a chatbot says turns on how much control it has, and warned that the line may blur as brands work to shape the information third-party chatbots relay.
HBW Insight - October 22, 2026
NRx Looks To Pin Down Name For Preservative-Free Ketamine Ahead Of FDA Goal Date
NRx Pharmaceuticals has received a discipline review letter from the US Food and Drug Administration requesting "minor” changes to the submitted label for its preservative-free ketamine ahead of its Nov. 10 GDUFA goal date, including the product’s proprietary name that is currently under review.
Generics Bulletin - October 22, 2026
NRx Pharmaceuticals has received a discipline review letter from the US Food and Drug Administration requesting "minor” changes to the submitted label for its preservative-free ketamine ahead of its Nov. 10 GDUFA goal date, including the product’s proprietary name that is currently under review.
Generics Bulletin - October 22, 2026
Alvotech To Double Humira Biosimilar Output With New Process Approval From US FDA
FDA approval of a new adalimumab manufacturing process and a second drug substance suite in Reykjavik will more than double Alvotech's Simlandi batch output while freeing capacity for its broader biosimilar portfolio.
Generics Bulletin - October 22, 2026
FDA approval of a new adalimumab manufacturing process and a second drug substance suite in Reykjavik will more than double Alvotech's Simlandi batch output while freeing capacity for its broader biosimilar portfolio.
Generics Bulletin - October 22, 2026
Par Issues A Trio Of Recalls After FDA Warning Letter
Par Health has issued three US recall notices for injectables within a month of each other due to the presence of particulate matter. The recalls form part of remediation efforts for its site in Rochester, Michigan following receipt of an FDA warning letter in April 2026.
Generics Bulletin - October 22, 2026
Par Health has issued three US recall notices for injectables within a month of each other due to the presence of particulate matter. The recalls form part of remediation efforts for its site in Rochester, Michigan following receipt of an FDA warning letter in April 2026.
Generics Bulletin - October 22, 2026
CAR-T’s $12bn Future Hinges On More Than New Approvals
CAR-T sales are forecast to nearly double by 2032 but sustaining that growth will hinge on earlier-line adoption, next-gen platforms and the ability to overcome mounting competition and access barriers.
In Vivo - October 22, 2026
CAR-T sales are forecast to nearly double by 2032 but sustaining that growth will hinge on earlier-line adoption, next-gen platforms and the ability to overcome mounting competition and access barriers.
In Vivo - October 22, 2026
7 Major Changes MHRA Promises For 2030, As It Navigates Increasing EU Uncertainty
The MHRA’s 2030 Strategy promises a regulator that is more responsive, more proportionate and more international – but industry bodies want more details.
In Vivo - October 22, 2026
The MHRA’s 2030 Strategy promises a regulator that is more responsive, more proportionate and more international – but industry bodies want more details.
In Vivo - October 22, 2026