25 July 2024 - PDUFA goal date of 28 December 2024 set by FDA. ...
25 July 2024 - Mirum Pharmaceuticals today announced that the US FDA has approved a label expansion for Livmarli (maralixibat) oral ...
25 July 2024 - NDA submission on track for second half 2024. ...
25 July 2024 - Treatment of first randomised person with pre-clinical Alzheimer's disease expected this quarter. ...
24 July 2024 - Now approved for children of all ages with CLN2 Batten disease, regardless of whether they yet ...
23 July 2024 - Once daily Zorvye foam significantly improved both scalp and body psoriasis in a Phase 2b and a ...
23 July 2024 - Findings from the House Oversight investigation add to criticism that pharmacy-benefit managers are driving up drug spending. ...
24 July 2024 - The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package ...
24 July 2024 - ConSynance Therapeutics today announced that the US FDA has granted rare paediatric disease designation to its ...
24 July 2024 - Tiziana Life Sciences today announced the US FDA has granted fast track designation for its intranasal formulation ...
23 July 2024 - Jeffrey Shuren, longtime chief regulator of medical devices at the FDA, announced to staff on Tuesday ...
23 July 2024 - Ozuriftamab vedotin, the Company’s conditionally and reversibly active antibody drug conjugate directed against ROR2, has shown promising ...
22 July 2024 - The agency has repeatedly neglected its obligation to ensure that drugs are effective. ...
23 July 2024 - The FDA designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and ...
23 July 2024 - Mesoblast announced that the US FDA has accepted its biologics license application resubmission for Ryoncil (remestemcel-L) ...