Policy & Regulation
BioArctic and Eisai report FDA extension of Leqembi Iqlik review
8 May 2026 - Swedish research-based biopharma company BioArctic AB (STO:BIOA-B) and its Japanese partner Eisai Co Ltd (TYO:4523) announced on Friday that the US Food and Drug Administration (FDA) has ...
Mezzion reveals pre-IND FDA feedback on udenafil development in ADPKD
8 May 2026 - South Korean biopharmaceutical company Mezzion Pharma Co Ltd on Thursday announced written feedback from the US Food and Drug Administration (FDA) following a pre-IND Type C Guidance meet...
Chance Pharma reports NMPA acceptance of NDA for investigational respiratory drug CXG87
8 May 2026 - Chance Pharmaceuticals, a clinical-stage biotech company focused on the research and development of innovative dry powder inhalation (DPI) therapies, announced on Thursday that the Center...
Altasciences and Certara form strategic partnership to accelerate early drug development
7 May 2026 - Drug development solution company Altasciences announced on Thursday that it has entered into a strategic partnership with biosimulation software specialist Certara Inc (NASDAQ:CERT) to a...
Partner Therapeutics' BIZENGRI receives FDA Commissioner's National Priority Voucher for NRG1 fusion-positive cholangiocarcinoma
7 May 2026 - Biotechnology company Partner Therapeutics Inc (PTx) announced on Wednesday that the US Food and Drug Administration (FDA) has awarded a Commissioner's National Priority Voucher (CNP...
Diakonos Oncology's DOC1021 granted US FDA Fast Track Designation for unresectable or metastatic cutaneous melanoma
7 May 2026 - Clinical-stage biotechnology company Diakonos Oncology Corp announced on Wednesday that the US Food and Drug Administration (FDA) has granted Fast Track designation to DOC1021 (dubodencel...