Latest Pharma Insights
FDA Proposes To Reclassify Blue-Light Cystoscopy Systems, Opens Karl Storz–Photocure Bladder Cancer
The FDA has proposed downclassifying blue-light bladder cancer cystoscopy systems from Class III to Class II, swapping the PMA requirement for a 510(k) and opening a category long held by Karl Storz and Photocure to new entrants.
Medtech Insight - August 20, 2026
The FDA has proposed downclassifying blue-light bladder cancer cystoscopy systems from Class III to Class II, swapping the PMA requirement for a 510(k) and opening a category long held by Karl Storz and Photocure to new entrants.
Medtech Insight - August 20, 2026
After Two Decades Under PMA, Oncology ISH Companion Tests Get A Lighter Regulatory Path
FDA's final order moves oncology ISH tests from Class III to Class II, effective Sept. 16, replacing PMA with 510(k). The agency dropped a reagent-stability special control, added surrogate-sample flexibility, and flagged that no AI-enabled digital pathology version is authorized.
Medtech Insight - August 20, 2026
FDA's final order moves oncology ISH tests from Class III to Class II, effective Sept. 16, replacing PMA with 510(k). The agency dropped a reagent-stability special control, added surrogate-sample flexibility, and flagged that no AI-enabled digital pathology version is authorized.
Medtech Insight - August 20, 2026
Estée Lauder Restructuring Hits Mark; Innovation Drives Next Phase
Estée Lauder says its sweeping organizational overhaul has restored sales and profitability momentum, setting the stage for a more aggressive growth push in fiscal 2027.
HBW Insight - August 20, 2026
Estée Lauder says its sweeping organizational overhaul has restored sales and profitability momentum, setting the stage for a more aggressive growth push in fiscal 2027.
HBW Insight - August 20, 2026
Genmab Speeds Toward New Product Launches In 2027
After the company updated the timing of Phase III readouts for Epkinly in first-line DLBCL and for wholly owned candidates Rina-S and petosemtamab, Scrip spoke with chief commercial officer Brad Bailey about launch preparations.
Scrip - August 19, 2026
After the company updated the timing of Phase III readouts for Epkinly in first-line DLBCL and for wholly owned candidates Rina-S and petosemtamab, Scrip spoke with chief commercial officer Brad Bailey about launch preparations.
Scrip - August 19, 2026
Pasatru’s FDA Approval Puts Regeneron’s Rare-Disease Playbook To The Test
The US FDA approved the anti-activin A drug for fibrodysplasia ossificans progressiva, an ultra-rare disorder in which soft tissue is converted to bone.
Scrip - August 19, 2026
The US FDA approved the anti-activin A drug for fibrodysplasia ossificans progressiva, an ultra-rare disorder in which soft tissue is converted to bone.
Scrip - August 19, 2026
Lundbeck Lays Foundation To Scale Up From 2027
The Danish drugmaker can boast a transformed pipeline and steady revenue rises that should ensure a sustainable healthy future, according to CEO Charl van Zyl.
Scrip - August 19, 2026
The Danish drugmaker can boast a transformed pipeline and steady revenue rises that should ensure a sustainable healthy future, according to CEO Charl van Zyl.
Scrip - August 19, 2026
Moderna And Merck’s mRNA Cancer Combo Shines In Phase III Melanoma Trial
Moderna shares nearly doubled premarket on the topline, with detailed results due at an upcoming medical meeting and overall survival still maturing.
Scrip - August 19, 2026
Moderna shares nearly doubled premarket on the topline, with detailed results due at an upcoming medical meeting and overall survival still maturing.
Scrip - August 19, 2026
Regeneron’s Uveitis Setback Adds To String Of Recent Pipeline Challenges
Regeneron’s latest pipeline setback puts fresh focus on its remaining ophthalmology bets and the broader slate of clinical catalysts that will shape its growth outlook.
Scrip - August 19, 2026
Regeneron’s latest pipeline setback puts fresh focus on its remaining ophthalmology bets and the broader slate of clinical catalysts that will shape its growth outlook.
Scrip - August 19, 2026
HUTCHMED Advances Global Early Trials For First-In-Class Conjugates
HUTCHMED’s Guangxiu Dai talks to Scrip about the firm’s first-in-class antibody-targeted therapy conjugates and strategies for cross-border partnerships.
Scrip - August 19, 2026
HUTCHMED’s Guangxiu Dai talks to Scrip about the firm’s first-in-class antibody-targeted therapy conjugates and strategies for cross-border partnerships.
Scrip - August 19, 2026
FDA Proposes To Reclassify Blue-Light Cystoscopy Systems, Opens Karl Storz–Photocure Bladder Cancer
The FDA has proposed downclassifying blue-light bladder cancer cystoscopy systems from Class III to Class II, swapping the PMA requirement for a 510(k) and opening a category long held by Karl Storz and Photocure to new entrants.
Medtech Insight - August 20, 2026
The FDA has proposed downclassifying blue-light bladder cancer cystoscopy systems from Class III to Class II, swapping the PMA requirement for a 510(k) and opening a category long held by Karl Storz and Photocure to new entrants.
Medtech Insight - August 20, 2026
After Two Decades Under PMA, Oncology ISH Companion Tests Get A Lighter Regulatory Path
FDA's final order moves oncology ISH tests from Class III to Class II, effective Sept. 16, replacing PMA with 510(k). The agency dropped a reagent-stability special control, added surrogate-sample flexibility, and flagged that no AI-enabled digital pathology version is authorized.
Medtech Insight - August 20, 2026
FDA's final order moves oncology ISH tests from Class III to Class II, effective Sept. 16, replacing PMA with 510(k). The agency dropped a reagent-stability special control, added surrogate-sample flexibility, and flagged that no AI-enabled digital pathology version is authorized.
Medtech Insight - August 20, 2026
Estée Lauder Restructuring Hits Mark; Innovation Drives Next Phase
Estée Lauder says its sweeping organizational overhaul has restored sales and profitability momentum, setting the stage for a more aggressive growth push in fiscal 2027.
HBW Insight - August 20, 2026
Estée Lauder says its sweeping organizational overhaul has restored sales and profitability momentum, setting the stage for a more aggressive growth push in fiscal 2027.
HBW Insight - August 20, 2026
How Celltrion Is Making A Splash In Tenders, Formularies And Pharmacies
Celltrion’s newer biosimilars are translating European tender wins and US reimbursement gains into market share, supporting a stronger sales mix and margin expansion heading into the second half.
Generics Bulletin - August 19, 2026
Celltrion’s newer biosimilars are translating European tender wins and US reimbursement gains into market share, supporting a stronger sales mix and margin expansion heading into the second half.
Generics Bulletin - August 19, 2026
Outlook To Expand Ophthalmic Bevacizumab Empire With Pre-Filled Presentation
Outlook Therapeutics is exploring a pre-filled syringe version of its ophthalmic bevacizumab Lytenava, while eyeing Latin America, Asia, and MENA for further deals.
Generics Bulletin - August 19, 2026
Outlook Therapeutics is exploring a pre-filled syringe version of its ophthalmic bevacizumab Lytenava, while eyeing Latin America, Asia, and MENA for further deals.
Generics Bulletin - August 19, 2026
Semaglutide Sole-Supplier Status Brings Both Rewards And Challenges For Apotex In Canada
Apotex has found itself left as the only supplier of generic semaglutide in Canada after Dr Reddy’s dropped out and Aspen was unable to launch. But while the Canadian firm is reaping commercial benefits, it is also having to step up supply to meet demand.
Generics Bulletin - August 19, 2026
Apotex has found itself left as the only supplier of generic semaglutide in Canada after Dr Reddy’s dropped out and Aspen was unable to launch. But while the Canadian firm is reaping commercial benefits, it is also having to step up supply to meet demand.
Generics Bulletin - August 19, 2026
Bio-Thera Expands Dupixent Biosimilar Reach With MENA Deal
Bio-Thera has handed Avalon Pharma exclusive MENA rights to its proposed Dupixent biosimilar BAT2406, extending its international commercialization network as competition builds around the $17.8bn biologic.
Generics Bulletin - August 19, 2026
Bio-Thera has handed Avalon Pharma exclusive MENA rights to its proposed Dupixent biosimilar BAT2406, extending its international commercialization network as competition builds around the $17.8bn biologic.
Generics Bulletin - August 19, 2026
Sandoz’s Generics-Biosimilars Split Reaches US Leadership
Sandoz has appointed separate US heads for generics and biosimilars, extending its global push to give the two businesses more distinct leadership as their commercial dynamics increasingly diverge.
Generics Bulletin - August 19, 2026
Sandoz has appointed separate US heads for generics and biosimilars, extending its global push to give the two businesses more distinct leadership as their commercial dynamics increasingly diverge.
Generics Bulletin - August 19, 2026
Regeneron’s Lowy Bets Combinations Will Carry Its Oncology Business Past PD-1
Regeneron built a PD-1 franchise approaching $2bn in annual sales, then bet on antibody combinations, bispecifics and radiopharma. The biology is sound but execution, toxicity and trial design remain challenges.
In Vivo - August 19, 2026
Regeneron built a PD-1 franchise approaching $2bn in annual sales, then bet on antibody combinations, bispecifics and radiopharma. The biology is sound but execution, toxicity and trial design remain challenges.
In Vivo - August 19, 2026
The $2.2tn Efficiency Gap: Who Got Their Money’s Worth?
The top 15 drugmakers spent $2.2tn over a decade. Only BMS and Takeda destroyed value; Lilly, Novo Nordisk and AstraZeneca converted spending into outsized value.
In Vivo - August 19, 2026
The top 15 drugmakers spent $2.2tn over a decade. Only BMS and Takeda destroyed value; Lilly, Novo Nordisk and AstraZeneca converted spending into outsized value.
In Vivo - August 19, 2026