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Results For "regulatory"

1664 News Found

Teva hits major biosimilar milestones with FDA nod and regulatory filings
Drug Approval | March 31, 2026

Teva hits major biosimilar milestones with FDA nod and regulatory filings

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


Alcon walks away from LENSAR deal after regulatory roadblock
News | March 19, 2026

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
Clinical Trials | March 14, 2026

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
News | February 12, 2026

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
Medical Device | January 01, 2026

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,


Qure.ai receives regulatory clearance for AI tool for early detection of TB in children below 3 years
Technology | October 22, 2025

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


Evofem's SOLOSEC submitted for regulatory approval in the UAE
News | October 06, 2025

Evofem's SOLOSEC submitted for regulatory approval in the UAE

Marks first international filing for Evofem’s single-dose oral treatment


DMMA warns regulatory burden threatening Gujarat’s pharma MSMEs
Policy | September 26, 2025

DMMA warns regulatory burden threatening Gujarat’s pharma MSMEs

The association called for an end to the constant issuance of regulatory circulars that make operations unpredictable and capital-intensive.


iPHEX 2025: Global regulatory conclaves to highlight India’s role in shaping global health
News | September 03, 2025

iPHEX 2025: Global regulatory conclaves to highlight India’s role in shaping global health

This year’s edition will witness participation of over 700 Indian exporters showcasing their products and services; 500+ overseas delegates representing more than 120 countries; 20,000 domestic visitors; and 8,000+ B2B meetings