Pharmaceutical Research and Manufacturers of America makes the case for amending Federal Rule of Evidence 702 to help dismiss speculative expert opini...
CDER issues a MAPP on ANDA information requests and discipline review letters.
Philips Respironics recalls certain Trilogy Evo ventilators due to potential health risks caused by a polyester-based polyurethane sound abatement foa...
FDA approves an Immunocore BLA for Kimmtrak (tebentafusp-tebn) for treating certain adult patients with unresectable or metastatic uveal melanoma.
FDA places a partial clinical hold on Gilead Sciences studies evaluating the combination of magrolimab plus azacitidine (Celgenes Vidaza) due to an ap...
FDA warns Aurobindo Pharmaceutical about repeat CGMP deviations in the manufacturing of active pharmaceutical ingredients at its plant in Doultabad, T...
Former dissident CBER Office of Vaccines Research and Review deputy director Philip Krause joins Adjuvance Technologies as a strategic consultant.
FDA publishes a guidance on using patient engagement to support the design and conduct of medical device clinical studies.