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In the midst of a pandemic, if you wait for all the data to come in, “you’ve missed the boat,” said FDA Commissioner Robert Califf yesterday regarding the agency authorizing both Pfizer/BioNTech’s and Moderna’s bivalent COVID-19 boosters before any clinical trials on them are complete. Read More
Inadequate procedures to minimize the risk of contamination earned Lupin Limited a Form 483 following a March 22 to April 4 FDA inspection of its facility in Palghar, Maharashtra, India. Read More
Neurocrine Biosciences has made a bid for the UK-based Diurnal Group, a move that could pull in a phase 3 candidate for treating congenital adrenal hyperplasia (CAH). Read More
The University of Michigan and University of South Florida are suing Novartis for patent infringement, claiming that the pharma giant used a complex method of crystal engineering developed by their researchers to design the heart failure drug Entresto, a combination of sacubitril and valsartan. Read More
A new study of cancer drugs awarded FDA accelerated approval debunks the theory that drugmakers benefit financially from postmarket confirmatory trials that support the approval. Read More