Policy & Regulation
Insmed's ARIKAYCE sNDA granted priority review by FDA
21 September 2026 - Biopharmaceutical company Insmed Incorporated (Nasdaq: INSM) disclosed on Monday that the US Food and Drug Administration has accepted its supplemental New Drug Application for ARI...
Precigen announces FDA platform technology designation for AdenoVerse
21 September 2026 - Biopharmaceutical company Precigen Inc (Nasdaq: PGEN) disclosed on Monday that it has received US Food and Drug Administration platform technology designation for its AdenoVerse im...
Enhertu recommended for EU approval in early HER2-positive breast cancer
21 September 2026 - British-Swedish biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (NYSE:AZN) and Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) announced on Monday that E...
PureTech receives FDA Fast Track designation for LYT-200 in HR-MDS
21 September 2026 - Biotherapeutics company PureTech Health plc (LSE: PRTC) announced on Monday that it has completed a successful End-of-Phase 1 meeting with the U.S. Food and Drug Administration and...
CHMP recommends EU approval of Klygefa for generalised myasthenia gravis
21 September 2026 - Biopharmaceutical company AstraZeneca PLC (STO: AZN; LON: AZN; NYSE: AZN) said on Monday it has received a positive opinion from the Committee for Medicinal Products for Human Use ...
Zealand Pharma's Zeydovio (glepaglutide) receives positive CHMP opinion for short bowel syndrome treatment
21 September 2026 - Danish biotechnology company Zealand Pharma A/S (Nasdaq: ZEAL) announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (...