FDA setback for Sanofi’s Tolebrutinib in progressive MS

Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity

IRLAB launches Phase Ib Trial of IRL757 for Parkinson’s patients with Apathy

The multicenter study will enroll 75 patients across 16 sites in Germany, Bulgaria, Poland, and Spain

Amneal and mAbxience score FDA green light for two Denosumab biosimilars

Kashiv BioSciences secures Rs. 684 crore funding to build one of India’s largest biopharma facilities

The new single-use commercial facility will be among India’s largest, featuring advanced technologies to produce high-quality biologics and specialty pharmaceuticals

Biocon inks out-licensing agreement with Ajanta to market Semaglutide in 26 countries

Biocon will be responsible for supplying Semaglutide to Ajanta for exclusive marketing in 23 countries and semi-exclusive marketing in 3 countries across Africa, Middle East and Central Asia

MARAbio launches first blood test to detect maternal autoantibody-linked autism

The MAR-Autism Test represents more than 20 years of research at the UC Davis MIND Institute by Judy Van de Water

Emcure Pharma launches weight loss drug Poviztra in India

Emcure becomes the first Indian company to exclusively distribute and commercialise Poviztra, a second brand of Novo Nordisk’s Semaglutide injection for weight management

SandboxAQ, MapLight team up to target novel CNS therapy with AI-driven drug discovery

SandboxAQ will receive an upfront payment and could earn up to $200 million in milestone payments tied to preclinical, development, regulatory, and commercial achievements

Novo Nordisk files FDA application for once-weekly obesity drug CagriSema

If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection

GenSci, RTW & Yarrow Bioscience strike $1.365 billion global deal for breakthrough graves’ disease therapy

GS-098, a first-in-class, humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor, is designed to rapidly block the pathogenic activity of thyroid-stimulating autoantibodies