U.S. FDA places clinical hold on BioNTech's malaria vaccine study
BioNTech said in a regulatory filing on Tuesday the U.S. Food and Drug Administration has placed a clinical hold on an ...
Trump’s FDA Cuts Are Putting Drug Development at Risk
New SEC filings from pharmaceutical companies reveal Donald Trump and Elon Musk’s cost-cutting measures could slow drug ...
Managed Healthcare Executive23h
FDA Accepts Amneal’s BLA for Two Denosumab Biosimilars
The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.
FDA cancels pivotal advisory meeting about next season's flu vaccine
An FDA vaccine advisory committee meeting to discuss next season’s flu vaccine has been canceled, potentially delaying the ...
BioNTech reports FDA clinical hold on Phase I/IIa trial of BNT165e
In a regulatory filing, BioNTech (BNTX) disclosed that the U.S. Food and Drug Administration has informed BioNTech SE that it has placed a ...
Modern Healthcare6d
GLP-1 compounding pharmacies sue FDA over shortage decision
Outsourcing Facilities Association and North American Custom Laboratories allege the FDA removed semaglutide from its ...
BioSpace8d
Compounders Sue FDA for Declaring Ozempic, Wegovy Shortage Over
The Outsourcing Facilities Association, a trade group representing compounders, filed a similar lawsuit in October last year ...
VANTAGE FILES FDA DRUG MASTER FILE FOR VYCERIN™ API GLYCERIN, USP DESIGNED SPECIFICALLY TO MEET PHARMACEUTICAL FORMULATION NEEDS
Vantage Specialty Chemicals, Inc., (Vantage) today announced that its VYCERIN™ API Glycerin, USP is listed on the Drug Master File (DMF-040171) with the U.S. Food and Drug Administration (FDA). This ...
Florida Politics2d
Jay Trumbull, James Buchanan file bills to make stem cell therapy more available
Trumbull’s bill is aiming to tap into the significant potential of stem cell therapies in advancing medical treatments and ...
FDA moves to rehire medical device, food safety and other staffers fired days earlier
FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew ...