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4734 News Found

Lupin receives EIR from USFDA for Nagpur injectable facility
Drug Approval | December 17, 2025

Lupin receives EIR from USFDA for Nagpur injectable facility

The EIR was issued following an inspection of the facility from September 8 to September 16, 2025


AstraZeneca wins EU nod for self-administered lupus drug Saphnelo
News | December 17, 2025

AstraZeneca wins EU nod for self-administered lupus drug Saphnelo

Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion


Bristol Myers Squibb launches AI-powered ‘Mosaic’ hub in Mumbai
News | December 17, 2025

Bristol Myers Squibb launches AI-powered ‘Mosaic’ hub in Mumbai

India plays a critical role in Bristol Myers Squibb’s global strategy


Gujarat Kidney and Super Speciality to file IPO at Rs.108- Rs.114 per share
News | December 17, 2025

Gujarat Kidney and Super Speciality to file IPO at Rs.108- Rs.114 per share

The company operates a chain of mid-sized multi-speciality hospitals


FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
Biopharma | December 16, 2025

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease


Ind-Swift Laboratories receives GMP compliance certificate from NNGYK-Hungary
News | December 16, 2025

Ind-Swift Laboratories receives GMP compliance certificate from NNGYK-Hungary

The said certificate is valid for a period of 3 years and opens up the European and other markets for the company's products


Sanofi secures two breakthrough nods in China for rare blood disorders
News | December 16, 2025

Sanofi secures two breakthrough nods in China for rare blood disorders

Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia


Neuren partner Acadia bags FDA go-ahead for new DAYBUE STIX powder for Rett Syndrome
Drug Approval | December 16, 2025

Neuren partner Acadia bags FDA go-ahead for new DAYBUE STIX powder for Rett Syndrome

The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste