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5191 News Found

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


Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga
News | December 15, 2025

Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga

Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility


Eiko LifeSciences to acquire 51% stake in SSM Formulations
News | December 15, 2025

Eiko LifeSciences to acquire 51% stake in SSM Formulations

The plant can reach an annual capacity of 300 crore tablets and 90 crore capsules


Thermo Fisher Scientific appoints Anoopa Menon as Director
People | December 14, 2025

Thermo Fisher Scientific appoints Anoopa Menon as Director

In her previous roles, Menon led significant digital transformation efforts, implementing predictive analytics, automation