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DifGen Pharmaceuticals' single injection treatment for advanced breast cancer cleared for clinical development
28 July 2026 - Generic pharmaceuticals manufacturer DifGen Pharmaceuticals LLC announced on Monday that the US Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application and issued a 'study may ...
AbelZeta's C-CAR168 registrational Phase II trial in refractory Lupus Nephritis granted FDA clearance
28 July 2026 - Clinical-stage biopharmaceutical company AbelZeta Pharma Inc announced on Monday the receipt of US Food and Drug Administration (FDA) clearance under its Regenerative Medicine Advanced Therapy (RMAT) designation regarding the multiple-...
CSL reports positive top-line Phase 3b results for ANDEMBRY (garadacimab-gxii) in children with HAE
28 July 2026 - Australia-based global biotechnology company CSL (ASX:CSL; USOTC:CSLLY) announced on Monday positive top-line Phase 3b results evaluating ANDEMBRY (garadacimab-gxii) in children aged 2 to 11 years with hereditary angioedema (HAE).ANDEM...
Decoy Therapeutics expands antiviral platform into Ebola and filovirus research
27 July 2026 - Biotechnology company Decoy Therapeutics Inc (Nasdaq: DCOY) reported on Monday that a D-MAV antiviral candidate demonstrated in vitro activity against wild-type Ebola Zaire virus, expanding the company's Designable Multi-Antiviral...
AcuCort secures renewed FDA fee waiver ahead of planned NDA submission
27 July 2026 - Swedish pharmaceutical company AcuCort AB (Spotlight Stock Market: ACUC), developer of the rapidly dissolving dexamethasone oral film Zeqmelit, said on Monday it has received a renewed Small Business Waiver from the US Food and Drug Ad...