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

WHO report reveals stark global inequities in genomic research

EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP

Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation

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

Japan nod to Dupixent for children with severe asthma

The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies