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6841 News Found

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection
Drug Approval | October 05, 2025

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial


FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer
Drug Approval | October 05, 2025

FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study


Amgen’s Phase III data supports FDA label expansion of Repatha
News | October 05, 2025

Amgen’s Phase III data supports FDA label expansion of Repatha

Repatha is now the first and only PCSK9 inhibitor to demonstrate significant reduction of cardiovascular events as both primary and secondary prevention


Lupin launches Liraglutide injection in US
News | October 04, 2025

Lupin launches Liraglutide injection in US

Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen is bioequivalent to Victoza Injection, 18 mg/3 mL (6 mg/mL) of Novo Nordisk


Genmab to acquire Merus for $8 billion
News | October 03, 2025

Genmab to acquire Merus for $8 billion

Proposed acquisition adds petosemtamab, a late-stage asset with two Breakthrough Therapy Designations, to Genmab’s portfolio


A. P. Rameswara Rao appointed National President of BDMAI
People | October 03, 2025

A. P. Rameswara Rao appointed National President of BDMAI

A Post Graduate in Science faculty and has a wide experience spanning over 35 years in the field of manufacturing Bulk Drugs and Active Pharmaceutical Intermediaries


Lupin receives FDA approval Rivaroxaban for oral suspension
Drug Approval | October 01, 2025

Lupin receives FDA approval Rivaroxaban for oral suspension

The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India


Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections
Drug Approval | October 01, 2025

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company