The US Food and Drug Administration (FDA) has granted fast track designation for GC Biopharma and Novel Pharma's GC1130A, a biological drug for the treatment of MPSIIIA (Sanfilippo syndrome Type A).
The US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) filed by Eisai for a monthly dose intravenous (IV) maintenance dose of Eisai and Biogen’s lecanemab-irmb (LEQEMBI) to treat early Alzheimer’s disease (AD).
Lucy Therapeutics (LucyTx) has secured $12.5m in additional financing round to advance the development of new treatments for Alzheimer's and Parkinson's diseases.
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.
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