Zydus gets USFDA final approval for generic Dapagliflozin with 180-day shared exclusivity

Immediate opportunity in the $10.2 billion U.S. market as the diabetes therapy will be manufactured at Zydus’ SEZ Ahmedabad facility

Samsung Biologics lands first US manufacturing facility with GSK acquisition

Samsung Biologics will continue supplying products previously manufactured at the site to GSK

Senores makes bold US push with new federal-focused JV

Company leadership is framing the move as transformational.

Sun Pharma flags mixed Fibromun trial results, advances new Phase III study in soft tissue sarcoma

The company has highlighted setbacks in Phase II studies while outlining fresh regulatory and late-stage development plans for Fibromun and Nidlegy

Merck secures landmark EU nod for KEYTRUDA in hard-to-treat ovarian cancer

Its a major breakthrough for women’s ovarian cancer care in Europe

Merck launches high-stakes trial of dual-action eye drug aiming to halt leading cause of blindness

The trial, dubbed MALBEC, marks the first in a broader late-phase development push for MK-8748, with a second NVAMD study expected to begin later this year

Nearly 40 industry groups unite to push for EU Biotech Act II

A joint position paper warns that Europe is the only major global region without a dedicated biomanufacturing initiative

Glenmark Pharmaceuticals accelerates U.S. strategy with direct RYALTRIS distribution

This marks a meaningful step in the company's continued expansion in the region

Wockhardt’s breakthrough antibiotic Zaynich wins key regulatory nod in India

Lupin receives FDA’s tentative approval for Sugammadex injection

Sugammadex injection is bioequivalent to Merck’s Bridion injection for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery