FDA releases the proposed recommendations for the eighth reauthorization of the Prescription Drug User Fee Act, outlining changes to drug review, manu...
Foundation for Prader-Willi Research warns that real-world reports of edema and other serious heart and respiratory problems among patients taking Neu...
The Department of Justice seeks an injunction to stop Steiner Biotechnology from manufacturing and marketing adulterated and misbranded dental medical...
FDA is raising questions about the risk/benefit of ADC Therapeutics Zynlonta as a second-line treatment for diffuse large B-cell lymphoma.
FDA issues a draft guidance proposing a risk-based framework for evaluating the container-closure systems used to package human drugs and biologics.
FDA releases the Form FDA-483 issued following an inspection at Indias Reliance Life Sciences drug manufacturing facility in Navi Mumbai.
FDA grants Bristol-Myers Squibb accelerated approval for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethason...
FDA officials detailing the agencys new expedited IND pilot program say a central feature will be a rolling pre-IND submission process.
