An FDA approval document shows that the accelerated approval of Replimunes Tudriqev came despite significant concerns about the reliability of efficac...
FDA has issued a warning letter to a Telangana, India, sterile drug manufacturing facility operated by Aurobindo Pharma subsidiary Eugia Pharma Specia...
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...
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 releases the Form FDA-483 issued following an inspection at Indias Reliance Life Sciences drug manufacturing facility in Navi Mumbai.
FDA releases the proposed recommendations for the eighth reauthorization of the Prescription Drug User Fee Act, outlining changes to drug review, manu...
