Independent Review Finds FDA Met MDUFA V Commitments, As PCCP Authorizations Triple
An independent Booz Allen Hamilton review found FDA has met its MDUFA V commitments to date. Authorized PCCPs rose to 88 in FY 2025 from 27 a year earlier, but 510(k) time to decision, a goal FDA shares with industry, keeps missing its target.
Medtech Insight - October 2, 2026

Regeneron’s Myostatin Inhibitor Preserves Muscle Mass In Phase II Obesity Study
Trevogrumab, a myostatin/GDF8-targeted antibody candidate, demonstrated ability to prevent lean-mass reduction in patients taking GLP-1 therapy for obesity.
Scrip - October 2, 2026

US FDA Principal Deputy COO Melissa Shea Departs For NIH
Shea joined the agency in April 2025 and helped oversee the consolidation of HR, IT and other functions into the Office of Operations.
Medtech Insight - October 2, 2026

Big Win For Small Patients: FDA Approves First Pediatric Heart Valve That Expands With Growth
The FDA has approved Edwards Lifesciences’ Autus Size-Adjustable Valve, a pediatric pulmonary heart valve designed to expand as a child grows. The novel device, the first agency-cleared valve with polymeric leaflets instead of animal tissue, could reduce repeat open-heart surgeries.
Medtech Insight - October 2, 2026

Rodan + Fields Shows How DTC Beauty Can Go Omnichannel
Rodan + Fields' President and CEO spoke with HBW Insight about the company’s push to build an omnichannel ecosystem and what it could mean for the brand’s next phase of growth.
HBW Insight - October 2, 2026

Finance Watch: Biopharmas Maintain Strong First-Day, Post-IPO Momentum
Public Company Edition: ADARx, the 22nd drug developer to go public in the US in 2026, closed its first day up 13.8% from its IPO price. Also, Viking closed a $575m offering, Pyxis priced an offering worth up to $282.6m and Scynexis inked a BARDA deal worth up to $214m.
Scrip - October 2, 2026

Pfizer Prepares Litfulo Filings In Growing Vitiligo Market
Detailed Phase III data for JAK3/TEC inhibitor Litfulo (ritlecitinib) in nonsegmental vitiligo were presented at EADV. Pfizer is talking to regulators about near-term filings for the drug, already approved for alopecia areata.
Scrip - October 2, 2026

Summit Deal Could Help Futureproof AstraZeneca’s Datroway
AstraZeneca and Daiichi-Sankyo are hoping Datroway can outshine Keytruda in lung cancer – but the new Summit deal anticipates ivonescimab becoming a future standard-of-care immune-oncology therapy.
Scrip - October 2, 2026

Hyloris Secures A Japanese Deal With Mikasaseiyaku For Maxigesic IV
Hyloris and AFT Pharmaceuticals have licensed Japan commercialization rights for Maxigesic IV (paracetamol/ibuprofen) to Mikasaseiyaku, extending a global partnership network that now covers more than 100 countries.
Generics Bulletin - October 2, 2026

Lendava Plant Opening Boosts Sandoz’s Biosimilars Capacity
A key piece of Sandoz’s ‘Bio100’ strategy has fallen into place with the opening of a major biosimilars manufacturing plant in Lendava, Slovenia.
Generics Bulletin - October 2, 2026

Foghorn Sounds The Alarm As Lilly Leaves Pact
As an oncology collaboration with the US giant comes to an end, the Massachusetts–based biotech is reprioritizing its pipeline and cutting 40% of its workforce.
Scrip - October 2, 2026

Accord And Bio-Thera Appeal After US Simponi Setback
After J&J’s Janssen succeeded in obtaining a US injunction preventing Accord and Bio-Thera from launching their FDA-approved Simponi biosimilars, the partners have hit back with an immediate appeal. But it is now unclear whether they will be able to launch golimumab as planned by the end of Q4.
Generics Bulletin - October 2, 2026

Proof of Concept - Can AI Outrun the Next Outbreak?
Jared Bauer, co-founder and CEO of Seek Labs, joins Proof of Concept to explain how his company's AI engine maps conserved targets across 145+ pathogens to build programmable CRISPR therapeutics and rapid, lab-free diagnostics.
In Vivo - October 2, 2026

Novartis Eyes Platform Benefits In $7.2bn Abogen Alliance
Novartis acquires bispecific T-cell engager with autoimmune promise and potentially other assets based on a novel platform from China's Abogen.
Scrip - October 2, 2026

Gilead’s Duty-To-Innovate Win: What The HIV Drug Ruling Means For Pharma Lifecycle Strategy
California's top court refused to hold Gilead liable for delaying a safer HIV drug to protect its franchise – a win for industry. But a parallel Canadian case, and a live split over what it means for lifecycle strategy, leave the duty-to-innovate question unsettled.
In Vivo - October 2, 2026

Brands Must Guide, Monitor Influencer and Media Claims – NAD Panel
Attorneys at NAD's 'Ad Law in Motion' conference in New York said that, under NAD’s definition of advertising, a brand can be held to claims made in influencer posts, press releases and interviews.
HBW Insight - October 2, 2026

ACNU Switches Have No ‘Moving Goalposts’ As FDA, Industry Gain Knowledge About Final Rule
“Now that we are trying to complete and devise some efforts about how to follow those requirements, it's sometimes being perceived as moving the goalposts,” says ONPD director Karen Murry.
HBW Insight - October 2, 2026