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Results For "FDA"

2194 News Found

Rafa Laboratories lands $186 million BARDA contract to develop life-saving trauma drug
R&D | November 23, 2025

Rafa Laboratories lands $186 million BARDA contract to develop life-saving trauma drug

Landmark studies have shown that rapid TXA administration can significantly reduce mortality


Merck’s WINREVAIR shows promise in phase 2 study for hard-to-treat pulmonary hypertension
Clinical Trials | November 21, 2025

Merck’s WINREVAIR shows promise in phase 2 study for hard-to-treat pulmonary hypertension

The drug is being tested for combined post- and precapillary pulmonary hypertension due to heart failure with preserved ejection fraction


Merck’s two-drug HIV regimen hits phase 3 success
Clinical Trials | November 21, 2025

Merck’s two-drug HIV regimen hits phase 3 success

The study successfully met its primary endpoint, demonstrating similar rates of viral suppression for DOR/ISL compared to Biktarvy at 48 weeks


Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification
News | November 21, 2025

Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification

Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub


Sudeep Pharma eyes Rs. 895 crore fundraising from debut on bourses
News | November 19, 2025

Sudeep Pharma eyes Rs. 895 crore fundraising from debut on bourses

The issue comprises a fresh issue of Rs. 95 crore and targeting a total raise of around Rs. 895 crore


Cardiol Therapeutics wins US patent protection for heart-disease drug platform
News | November 19, 2025

Cardiol Therapeutics wins US patent protection for heart-disease drug platform

The patent will lock in broad protection for the company’s lead therapy CardiolRx and its novel subcutaneous candidate CRD-38


Briefs: Zydus, Divi's Laboratories and Relonchem
News | November 17, 2025

Briefs: Zydus, Divi's Laboratories and Relonchem

FDA closes inspection at Zydus' oncology injectable manufacturing facility in SEZ1, Ahmedabad with 2 observations


Lupin launches long-acting Risperidone in US
News | November 17, 2025

Lupin launches long-acting Risperidone in US

This marks Lupin’s first commercial product leveraging PrecisionSphere, a proprietary long-acting injectable (LAI) technology