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...
FDA approves an Otonomy NDA for Otiprio (ciprofloxacin otic suspension) 6% for treating acute otitis externa (swimmers ear) caused by Pseudomonas aeru...