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Rocket Pharmaceuticals receives FDA clearance for gene therapy targeting BAG3-associated dilated cardiomyopathy
30 June 2025 - Late-stage biotechnology company Rocket Pharmaceuticals Inc (NASDAQ:RCKT) announced on Monday that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug application for RP-A701, a gene therapy targeting BAG...
hVIVO supports Cidara Therapeutics' positive Phase 2b influenza study results
30 June 2025 - hVIVO plc (AIM:HVO), a specialist in conducting human challenge trials across multiple infectious and respiratory indications, on Monday reported positive topline results from a Phase 2b field study conducted by Cidara Therapeutics (Na...
Sanofi's riliprubart receives orphan drug designation in Japan for CIDP
30 June 2025 - French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Monday that the Ministry of Health, Labour and Welfare in Japan has granted orphan drug designation to riliprubart (SAR445088), an investigational mon...
HUTCHMED gains China approval for ORPATHYS and TAGRISSO combination in lung cancer
30 June 2025 - Biopharmaceutical company HUTCHMED (China) Limited (Nasdaq:HCM) (AIM:HCM) (HKEX:13) announced on Monday that it has received approval from the China National Medical Products Administration for the combination of ORPATHYS (savolitinib)...
Navamedic's medical device OraFID approved as primary package for a pharmaceutical product
30 June 2025 - Norway-based pharmaceutical company Navamedic (OSE:NAVA) announced on Friday that the Swedish Medical Products Agency, acting as the Reference Member State, together with the Concerned Member States in nine additional countries have ap...
Mabwell and Qilu Pharmaceutical enter licence agreement for Albipagrastim alfa for Injection
30 June 2025 - Chinese biopharmaceutical company Mabwell (SH:688062) announced on Friday that its wholly-owned subsidiary T-mab has entered into an agreement with Qilu Pharmaceutical for Albipagrastim alfa for Injection (R&D code: 8MW0511).Under ...
FDA approval streamlines access to Bristol Myers Squibb CAR T cell therapies
27 June 2025 - Biopharmaceutical company Bristol Myers Squibb (NYSE:BMY) announced late Thursday that the US Food and Drug Administration has approved updated labels for its two CAR T cell therapies, reducing patient monitoring requirements and remov...