HRA Pharma files an NDA for an Rx-to-OTC switch for the companys Opill (norgestrel .075 mg), a progestin-only daily birth control pill.
After a 22-year career at FDA, CDER Office of Generic Drugs Division of Legal and Regulatory Support deputy director Martin H. Shimer II joins Lachman...
The National Hemophilia Foundation says FDA should require a REMS for two investigational gene therapies being reviewed as hemophilia treatments with ...
FDA clears a LiveMetric 510(k) for its LiveOne, a wrist-worn nano-sensor technology for monitoring blood pressure every 10 seconds.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Rhythm Pharmaceuticals Imcivree (setmelanotide ...
FDA issues AFT Pharmaceuticals a complete response letter on its NDA for Maxigesic IV, a combination of 1,000 mg paracetamol and 300 mg ibuprofen solu...
Royal Philips teams up with Biodesix to add the results of Biodesixs Nodify Lung blood-based lung nodule risk assessment testing into Philips Lung Can...
Genmab says it will submit in the second half of this year a BLA for subcutaneous epcoritamab, an investigational bispecific antibody for treating pat...