FDA
In briefing documents released Wednesday, the FDA raises doubts about two AstraZeneca assets set to be discussed Friday at the agency’s first drug-related advisory committee meeting in nine months.
Sanofi and Novartis kick off the heart of earnings season; Lilly strikes its fourth pact in as many weeks; Regeneron earns landmark approval for a gene therapy for a type of genetic deafness, and also strikes a White House deal; FDA asks Amgen to withdraw Tavneos and, separately, issues Commissioner’s National Priority Vouches to three unnamed psychedelics companies.
While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
The FDA in July 2025 made publicly available over 200 complete response letters—an initiative that the investment community sees as “unanimously positive,” analysts told BioSpace.
The deals keep rolling in, with Lilly penning a $7 billion pact for gene delivery biotech Kelonia Therapeutics and UCB taking over cell therapy-focused Neurona Therapeutics; President Trump signed a new executive order supporting the development of psychedelic therapies, sparking fanfare and concern alike; and the FDA’s recent Replimune decision has triggered broader debate about the agency’s flexibility.
In the U.S., Moderna withdrew its approval application for the combination vaccine in May last year and the timeline for resubmission remains uncertain.
The newly approved HIV drug Idvynso will also help Merck diversify as loss of exclusivity looms over its top-selling product, the mega-blockbuster cancer drug Keytruda.
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
Viatris, which Pfizer created in 2020, voluntarily withdrew extended-release products made at a plant in Ireland after an analysis revealed an issue that could affect bioavailability.
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