CDRH issues its annual report on the Accreditation Scheme for Conformity Assessment pilot program.
FDA publishes two guidances intended to help ANDA submissions.
Incyte says it is withdrawing an NDA for its parsaclisib to treat three lymphomas.
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...