FDA approves Italfarmaco’s Duvyzat for DMD treatment
The US Food and Drug Administration (FDA) has approved Italfarmaco's Duvyzat (givinostat) to treat Duchenne Muscular Dystrophy (DMD) in individuals aged six years and above.
The US Food and Drug Administration (FDA) has approved Italfarmaco's Duvyzat (givinostat) to treat Duchenne Muscular Dystrophy (DMD) in individuals aged six years and above.
Prilenia Therapeutics has announced its intention to submit a marketing authorization application (MAA) for pridopidine, aimed at treating Huntington's disease (HD), to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Kenai Therapeutics has secured $82m in Series A financing round for the development of next-generation allogeneic cell therapies targeting neurological disorders.
Sandoz has announced the launch of Tyruko (natalizumab), which was developed by Polpharma Biologics and claimed to be the first and only biosimilar to treat relapsing remitting multiple sclerosis (RRMS), in Germany.
AbbVie has announced the launch of Produodopa (foslevodopa/foscarbidopa), a new treatment for advanced Parkinson's disease (PD) patients in the European Union.
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.