Policy
The FDA is gearing up for six decisions in the next two weeks, two of which involve highly anticipated medicines for rare diseases.
FEATURED STORIES
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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The FDA’s Obstetrics Reproductive and Urologic Drugs Advisory Committee voted nearly unanimously to withdraw the approval of Covis’ preterm birth drug Makena.
Shares of Massachusetts-based Minerva Neurosciences dropped Monday after the FDA issued a Refuse to File letter for the company’s schizophrenia drug, roluperidone.
Biogen announced the FDA has extended its review for ALS drug tofersen by three months. The regulator set a new PDUFA action date set of April 25, 2023.
The FDA has numerous activities and interactions with Phanes, Prestige Biopharma, Reata, Pfizer and more, providing clearance, approving clinical trials and other regulatory actions.
The FDA is likely to push back the Prescription Drug User Fee Act target action date for Travere Therapeutics’ sparsentan by three months..
Tiziana Life Sciences plans to submit an Investigational New Drug Application for a Phase I trial studying intranasal formulab, a breakthrough treatment option for Alzheimer’s Disease.
On Friday, the FDA approved Boostrix, a vaccine administered during the third trimester of pregnancy to prevent pertussis in infants under 2 months of age.
The FDA’s Center for Drug Evaluation and Research issued its briefing documents arguing for the market withdrawal of Covis Pharma’s Makena and will discuss the drug on Oct. 17-19.
The FDA had a fairly quiet week, approving drugs, providing clearance, greenlighting clinical trials, and other regulatory activities for Alnylam, Eli Lilly, Cytokinetics, and more.
Eli Lilly gained ground in the obesity market Thursday as the FDA granted Fast Track designation to Mounjaro (tirzepatide), an investigational drug for adults with obesity.