A survey of 37 biotech executives shows FDA obstacles are sending more first-in-human trials overseas.
CDER associate Center director for strategic initiatives Theresa Mullin retires after 28 years at the agency.
FDA posts an updated guidance outlining procedures for formal meetings between the agency and sponsors or applicants developing or seeking approval fo...
FDA officials detailing the agencys new expedited IND pilot program say a central feature will be a rolling pre-IND submission process.
Eli Lilly files six new lawsuits against U.S. entities it alleges are selling illegal, unapproved retatrutide products.
The Justice Department says it has reached a deferred prosecution agreement with Veloxis Pharmaceuticals under which the company is paying $46 million...
Aquestive Therapeutics says that based on new human factor and pharmacokinetic trials of its Anophylm sought by FDA in a complete response letter, it ...
FDA releases the Form FDA-483 with three observations from a 2024 inspection at Indias MSN Life Sciences Unit II active pharmaceutical ingredient manu...
