FDA approves an Abiomed PMA for its expanded Impella CP heart pump with SmartAssist.
Three U.S. senators send a letter to Tri-Source Pharma CEO Robert DiCrisci, asking for an explanation on why a 40-year-old, off-patent cancer drug, lo...
Promius Pharma files an NDA New for its migraine candidate DFN-02, an intranasal formulation of sumatriptan 10 mg and Aegis Therapeutics permeation-en...
Federal Register notice: FDA makes available a draft five-year plan describing its approach to further implement a structured benefit-risk assessment ...
FDA clears a Zimmer Biomet Holdings 510(k) for its Comprehensive Augmented Baseplate, which is intended to offer an alternative to bone grafting and e...
FDA issues Alkermes a Refusal to File letter on its NDA for New ALKS 5461 (buprenorphine and samidorphan), a once-daily, oral investigational medicine...
Federal Register Final Rule; technical amendment: FDA amends its good guidance practices regulation to inform the public on how to electronically subm...
Federal Register notice: FDA announces a 5/11 public workshop on medical gas regulation entitled Medical Gas Regulation: Workshop 3.