Hormone therapy for menopause gets green light from FDA

The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature

Roche reports breakthrough phase III results for investigational multiple sclerosis drug

Fenebrutinib targets cells in the immune system known as B cells and microglia

Zydus receives China's NMPA approval for Venlafaxine ER capsules, 75 mg and 150 mg

FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma

Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition

EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours

Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1

BlueRock Therapeutics reports positive 36-month results from Phase I trial of bemdaneprocel for treating Parkinson’s disease

Investigational cell therapy bemdaneprocel continues to demonstrate a favorable safety profile at 36 months in Phase I trial participants

Hesperos and Bayer Consumer Health develop frst human-on-a-chip model of stress-induced cognitive dysfunction

New study presents a human-relevant stress model for assessing potential therapeutics

BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease

FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease

Leqembi wins NMPA nod for once-monthly IV dosing in early Alzheimer’s patients

LEQEMBI was initially approved in China in January 2024 for the treatment of Alzheimer’s disease in patients with mild cognitive impairment