FDA issues Fresenius Kabi a six-item FDA Form-483 after an inspection in May 2020 documented GMP deficiencies at its Melrose Park, IL manufacturing fa...
Wahl Clipper Corp. recalls all Deluxe Heat Therapy Massagers, Model 4212, due to overheating concerns.
Merck says Phase 3 data from the KEYNOTE-598 study evaluating Keytruda (pembrolizumab) in combination with Bristol-Myers Squibbs Yervoy (ipilimumab) c...
FDA approves a Biogen supplemental BLA for an intramuscular injection route of administration for Plegridy (peginterferon beta-1a), indicated for trea...
FDA Review posts the Federal Register notices for the week ending 1/29/2021.
Janssen and Novavax report positive data from Phase 3 clinical trials involving each of their investigational Covid-19 vaccines.
FDA extends by three months the review of a Biogen BLA for aducanumab, indicated for treating Alzheimers disease.
FDA approves a Medtronic PMA for the DiamondTemp Ablation system for treating patients with recurrent, symptomatic paroxysmal atrial fibrillation who ...