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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 ARIKAYCE (amikacin liposome inhalation suspension) fo...
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 immunotherapeutic platform, which underpins its firs...
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 Enhertu (trastuzumab deruxtecan) has been recommend...
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 received Fast Track designation for LYT-200 in co...
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 (CHMP) for Alexion, AstraZeneca Rare Disease'...