A federal appeals court affirms a lower court decision barring FDA from approving a Norwich ANDA for a generic form of Salix Xifaxan until 10/2/2029.
FDAer Susan Rosencrance tells the agencys Generic Drug Forum that FDA has chosen nine applicants to participate in a Quality Maturity Management evalu...
Federal Register notice: FDA determines that UCBs Kemstro (baclofen) orally disintegrating tablets, 10 mg and 20 mg, were not withdrawn from sale for ...
Federal Register notice: FDA determines that Pfizers Vistaril (hydroxyzine pamoate) oral suspension, 25 mg/5 mL, was not withdrawn from sale for reaso...
Two stakeholders comment positively on an FDA public meeting on advancing the use of complex innovative designs in clinical trials.
FDA authorizes Seattle Childrens Therapeutics to launch a CAR T-cell trial to treat lupus in children.
FDA clears a U.S. Army Biotechnology High Performance Computing Software Applications Institute 510(k) for an artificial intelligence-powered smartpho...
FDA grants Lisata Therapeutics an orphan drug designation for LSTA1 and its use in treating osteosarcoma.
