Capricor Therapeutics plans to amend its BLA for deramiocel to modify its proposed indication after discussions with FDA produced a potential path tow...
FDA grants Bristol-Myers Squibb accelerated approval for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethason...
FDA releases the Form FDA-483 issued following an inspection at Indias Reliance Life Sciences drug manufacturing facility in Navi Mumbai.
A Center for Medicine in the Public Interest opinion column calls on FDA to more aggressively recruit and use advisory committee temporary voting memb...
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.
