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FDA grants Amphix Bio a breakthrough device designation for its drug-device combination product for bone regeneration.[ Price : $8.95]
FDA approves Bristol Myers Squibbs Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as neoadjuvant treatment o...[ Price : $8.95]
FDA denies an Amneal Pharmaceuticals petition asking the agency to take several actions involving Provells Euthyrox (levothyroxine...[ Price : $8.95]
FDA clears an OrthAlign 510(k) for its Lantern Hip handheld technology for direct anterior total hip arthroplasty in patients in t...[ Price : $8.95]
Aldeyra Therapeutics resubmits an NDA for topical ocular reproxalap, an investigational new drug for treating signs and symptoms o...[ Price : $8.95]
Four stakeholders ask for clarifications and revisions in an FDA draft guidance on essential drug delivery outputs for devices int...[ Price : $8.95]
FDA says a Philips Respironics software correction for several ventilators was a Class 1 recall.[ Price : $8.95]
FDA releases the form FDA-483 with seven observations issued following an inspection at the Lorton, VA-based Annovex Pharma outsou...