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

Akeso’s novel AS drug Gumokimab accepted for review by China’s drug regulator

This marks the second indication for which gumokimab has gained NDA review acceptance

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,

UK’s healthcare regulator warns against dangerous online weight-loss drugs

Experts warn that illegal products may be fake, contaminated, incorrectly dosed, or contain powerful unlisted ingredients

Qure.ai receives regulatory clearance for AI tool for early detection of TB in children below 3 years

Breakthrough expands proactive TB screening from birth to 15 years, ensuring faster and more accurate diagnosis