Neurology

FDA grants orphan drug status for RedHill’s opaganib for neuroblastoma

The US Food and Drug Administration (FDA) has granted orphan drug designation to RedHill Biopharma's opaganib for the treatment of neuroblastoma, a childhood cancer.

FDA approves Alpha Cognition’s ZUNVEYL for Alzheimer’s treatment

The US Food and Drug Administration (FDA) has approved Alpha Cognition's oral therapy, ZUNVEYL, for the treatment of mild-to-moderate Alzheimer's disease.

Leqembi gains approval for Alzheimer’s treatment in Israel

BioArctic's partner Eisai has announced that Leqembi, has received approval in Israel for the treatment of Alzheimer's disease (AD), specifically for patients with mild cognitive impairment or mild dementia, the same stages targeted in clinical trials.

Augustine raises €17m to advance lead candidate into trials for neuro conditions

Augustine Therapeutics has secured €17m ($18.5m) in a Series A funding round's initial close for advancing its lead candidate, AGT100216, into a Phase I/II first-in-human clinical trial next year to treat neurological conditions.

Pyros Pharmaceuticals receives FDA approval for infantile spasms drug

Pyros Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for VIGAFYDE, marking it as the first and only ready-to-use vigabatrin oral solution, for infantile spasms (IS).

FDA grants fast track status for GC Biopharma and Novel Pharma’s GC1130A

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).

FDA accepts Eisai’s sBLA for intravenous LEQEMBI to treat early Alzheimer’s

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 secures $12.5m for neurological treatment development

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.

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.