FDA publishes a draft guidance on how it will use alternative tools to assess manufacturing facilities named in NDAs, ANDAs, BLAs, and their supplemen...
Travere Therapeutics says confirmatory trial data for accelerated approval therapy Filspari (sparsentan) will form the basis of a sNDA next year that ...
Three Hogan Lovells attorneys analyze a recent FDA guidance on using the ISO 10993-1 international standard for medical device biocompatibility.
An NPR report says FDA has received nearly 500 complaints about mental health issues patients associate with using semaglutide drugs such as Ozempic.
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) and its combination use with external beam radiotherapy plus con...
FDA grants orphan drug designation to Puma Biotechnologys small cell lung cancer investigative drug aliserib.
Federal Register notice: FDA reopens the comment period for the 4/4 notice entitled In-Home Disposal Systems for Opioid Analgesics; Request for Inform...
In an unusual move, FDA issues a statement about recent agency inspections at Novo Nordisks Clayton, NC manufacturing facility to quell concerns about...
