Kyverna Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for KYV-101, an autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate.
Voyager Therapeutics has chosen a lead development candidate for its superoxide dismutase 1 (SOD1)-mutated amyotrophic lateral sclerosis (ALS) gene therapy programme.
BridgeBio Pharma has entered into a strategic partnership with National Resilience (Resilience) for the manufacturing and advancement of two investigational gene therapies, BBP-812 and BBP-631.
Sage Therapeutics and Biogen have received approval from the US Food and Drug Administration (FDA) for ZURZUVAE (zuranolone) 50 mg to treat postpartum depression (PPD) in adults.
The Australian Therapeutic Goods Administration (TGA) has granted provisional approval to Hansa Biopharma’s Idefirix (imlifidase) as desensitisation treatment for highly sensitised patients before kidney transplantation either from living or deceased donors.
US-based amyloid diseases treatment solutions developer AltPep has raised $52.9m in its Series B investment round led by Senator Investment Group.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Marinus Pharmaceuticals’ ZTALMY (ganaxolone) oral suspension.
Denmark-based biotech firm Tetra Pharm Technologies has introduced its first product in Germany.
Clinical-stage biotechnology company QurAlis has closed $88m in oversubscribed Series B financing round to advance precision medicines for neurodegenerative diseases.
Avenue Therapeutics has signed an exclusive license agreement with Taiwanese clinical-stage drug company AnnJi Pharmaceutical to develop and commercialise the first-in-class clinical asset, AJ201.
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