FDA has released the form FDA-483 with five observations from an inspection at the Lakewood, CO-based BSO outsourcing facility.
FDA releases a list of 18 drug products for which there was a potential signal of serious risks or new safety information in the second quarter.
FDA grants Amphix Bio a breakthrough device designation for its drug-device combination product for bone regeneration.
FDA approves Bristol Myers Squibbs Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as neoadjuvant treatment of adults with resect...
FDA denies an Amneal Pharmaceuticals petition asking the agency to take several actions involving Provells Euthyrox (levothyroxine sodium).
FDA clears an OrthAlign 510(k) for its Lantern Hip handheld technology for direct anterior total hip arthroplasty in patients in the supine position.
Aldeyra Therapeutics resubmits an NDA for topical ocular reproxalap, an investigational new drug for treating signs and symptoms of dry eye disease.
Four stakeholders ask for clarifications and revisions in an FDA draft guidance on essential drug delivery outputs for devices intended to deliver dru...
