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...
FDA grants 23andMe a de novo marketing authorization for its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (selected variants) t...
FDA releases the FDA-483 with eight observations from a Philips Medical inspection.
Washington Legal Foundation says the 1st Circuit Appeals Court should reverse a lower court decision granting standing to bring suit to four unions wh...