FDA accepts for priority review a Genentech NDA for baloxavir marboxil, a single-dose, oral treatment for acute, uncomplicated influenza in people 12 ...
Federal Register notice: FDA announces a 7/26 Antimicrobial Drugs Advisory Committee meeting that will review a 60 Degrees Pharmaceuticals NDA for a m...
FDA accepts for review a Merck supplemental BLA for Keytruda, an anti-PD-1 infusion treatment for use as adjuvant therapy for patients with resected, ...
FDA releases the FDA-483 with six observations from a 2016 inspection at the Mylan finished drug manufacturing facility in Maharashta, India.
FDA releases an updated list of medication guides with three new and 22 updated guides.
FDA releases its latest batch of Warning Letters that includes one medical product company Henan Lihua Pharmaceutical Co.
FDA commissioner Scott Gottlieb says FDA will help drug innovators by publishing a list of surrogate endpoints used to approve or clear drugs or biolo...
CBER creates a new dialog avenue for biologic product developers to ask agency experts for advice on advancing a potential product.