FDA releases its latest batch of Warning Letters that includes Nan San (HK) Pharmaceutical Factory and Zhejiang Ludao Technology Co.
FDA expands the approval of St. Jude Medicals Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff to include a 15-mm valve size t...
Sen. Tina Smith introduces legislation to enable FDA to withdraw a generic drugs 180-days of exclusivity if it enters into a pay-for-delay agreement w...
CBERs Advertising and Promotional Labeling Branch cautions Behring that promotional materials for its Idelvion are misleading and make claims that ove...
FDA warns Chinas Zhejiang Ludao Technology Co. about CGMP and data integrity problems in its production of finished pharmaceuticals.
FDA releases the FDA-483 detailing nine inspection observations at Indias Aurobindo Pharma.
FDA releases an FDA-483 with three observations from an inspection at Indias Sun Pharmaceutical Industries.
FDA approves a TaiMed Biologics BLA for Trogarzo (ibalizumab-uiyk) for adult patients living with HIV who have tried multiple HIV medications in the p...