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...
FDA approves PreventionGenetics POMC/PCSK1/LEPR companion diagnostic genetic test for use with Rhythm Pharmaceuticals Imcivree (setmelanotide), indica...
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 11.
Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting consumer representative...
FDA says clinical trial results show an increased risk of death and serious side effects associated with Secura Bios cancer drug Copiktra.
FDA tells Covid-19 vaccine manufacturers seeking to update their vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike ...