Food and Drug Administration (FDA)
NEWS
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.
Theratechnologies’ Trogarzo for HIV, Alnylam’s Lumasiran for advanced primary hyperoxaluria, scPharmaceuticals’ Furoscix for heart failure and more. Here’s a look at the FDA’s October calendar.
The FDA granted rare pediatric disease designation to AVR-RD-04, an experimental gene therapy treatment for the lysosomal storage disease cystinosis, AVROBIO announced Tuesday.
Shares of Spectrum Pharmaceuticals plunged 33% upon the release of briefing documents for an FDA advisory meeting regarding poziotinib
Research on Alzheimer’s, specifically in neuroscience, continues with the Alzheimer’s Drug Discovery Foundation, Critical Path Institute, Abbvie, AlzeCure Pharma and more.
The FDA has a broad range of activities in the drug and medical device space. Here’s a look at the agency’s work this week.
The U.S. FDA approved Mallinckrodt’s Terlivaz in adults with hepatorenal syndrome and is the only FDA-approved drug for that indication.
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