FDA renews IQOS “reduced-risk” status backing PMI’s smoke-free strategy in regulatory win

The renewal covers two versions of the IQOS device and three HEETS tobacco variants

GSK wins regulatory boost for once-monthly liver drug efimosfermin in MASH push

The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need

Eli Lilly flags counterfeit Mounjaro products in Gurugram, backs regulatory action

Company confirms seized products were not from its authorised supply chain and urges patients to purchase medicines only through licensed pharmacies

CDSCO invites bids for next-gen Digital Drugs Regulatory System

API-first, DPI-driven DDRS platform aims to modernize drug and medical device regulation in India

Teva hits major biosimilar milestones with FDA nod and regulatory filings

The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia

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

Alcon walks away from LENSAR deal after regulatory roadblock

At the center of the collapse is opposition from the Federal Trade Commission

Veristat expands global trial & regulatory services as Chinese drugmakers push overseas

The expansion builds on Veristat’s work helping Chinese pharmaceutical firms such as Hansoh Pharma and CStone Pharmaceuticals

Hikal Q3 FY26: Revenue, EBITDA surge amid regulatory recovery

The pharmaceutical segment led growth, generating Rs. 337 crore in revenue, while the crop protection business contributed Rs. 157 crore

WORK Medical scores regulatory approval for AI-powered blood analyzer

It performs white blood cell differential counts and quantifies red blood cell and platelet morphology,