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Results For "FDA"

2290 News Found

Briefs: Emcure Pharmaceuticals and Gland Pharma
News | July 12, 2025

Briefs: Emcure Pharmaceuticals and Gland Pharma

Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility


OneSource Specialty Pharma appoints Jeffrey Wong as CBO
People | July 08, 2025

OneSource Specialty Pharma appoints Jeffrey Wong as CBO

He has held senior leadership positions at Syngene International, Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific, Sartorius Stedim Biotech, and other leading organizations


Everest Medicines progresses in AI-powered mRNA platform at 2025 R&D day
News | July 08, 2025

Everest Medicines progresses in AI-powered mRNA platform at 2025 R&D day

The company showcased three core programs developed through this platform


atai and Beckley Psytech announce positive Phase 2b results for treatment-resistant depression
News | July 04, 2025

atai and Beckley Psytech announce positive Phase 2b results for treatment-resistant depression

atai and Beckley Psytech plan to meet with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to finalize the Phase 3 trial design.


Alembic Pharmaceuticals acquires Utility Therapeutics for $12 million to strengthen US footprint
News | July 03, 2025

Alembic Pharmaceuticals acquires Utility Therapeutics for $12 million to strengthen US footprint

The acquisition of Pivya is an important step in Alembic’s ability to provide branded pharmaceutical product to the US Healthcare market


Briefs: Neuland Laboratories and Granules India
Drug Approval | June 29, 2025

Briefs: Neuland Laboratories and Granules India

Granules India receives 1 observation from USFDA for Chantilly facility


Lupin launches Prucalopride tablets in US
Drug Approval | June 27, 2025

Lupin launches Prucalopride tablets in US

Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA


Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma
Drug Approval | June 25, 2025

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA


Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer
News | June 24, 2025

Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

First and only TROP2-directed therapy approved in the US for the treatment of lung cancer


UFlex introduces FSSAI compliant single-pellet solution for food packaging
Packaging | June 20, 2025

UFlex introduces FSSAI compliant single-pellet solution for food packaging

UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials