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

Health Minister Nadda to launch Indian Pharmacopoeia 2026 in the first week of Jan. 2026

Indian Pharmacopoeia is now recognised in 19 countries, reflecting growing international confidence in India’s regulatory and scientific capabilities

Symbiosis rolls out first 10,000 vial batch at Stirling Facility

This production milestone positions Symbiosis at the forefront of meeting rising global demand for life-saving medicines

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

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR

Nona Biosciences expands platform to accelerate early clinical trials

Nona aims to help global biopharmaceutical companies fast-track clinical trial initiation without compromising scientific rigor or quality standards

Sanofi to acquire Dynavax in $2.2 billion deal, bolstering adult vaccine portfolio

The move strengthens Sanofi’s presence in adult immunization by combining Dynavax’s innovative vaccines with Sanofi’s global scale and development capabilities

Teva moves within reach of investment grade as S&P upgrades credit rating & Moody’s positive

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