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440 News Found

Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR
Drug Approval | January 09, 2026

Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR

This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million


Rapid-acting ADHD treatment Azstarys now approved in China
Drug Approval | January 08, 2026

Rapid-acting ADHD treatment Azstarys now approved in China

ADHD is a common, chronic neurodevelopmental disorder that often begins in childhood and can persist into adulthood


Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy
R&D | January 08, 2026

Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy

The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production


Briefs: Medicamen Biotech and Gland Pharma
Drug Approval | January 08, 2026

Briefs: Medicamen Biotech and Gland Pharma

Gland Pharma receives approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)


Wockhardt files marketing authorisation application for WCK 5222 with EMA
News | January 08, 2026

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation


FDA delays Corcept’s hypertension drug, seeks more evidence
Drug Approval | January 05, 2026

FDA delays Corcept’s hypertension drug, seeks more evidence

The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence


HUTCHMED’s Fanregratinib gains priority review in China for aggressive liver cancer
News | January 01, 2026

HUTCHMED’s Fanregratinib gains priority review in China for aggressive liver cancer

ICC is a highly aggressive liver cancer arising from the intrahepatic biliary epithelium


FDA setback for Sanofi’s Tolebrutinib in progressive MS
Drug Approval | December 27, 2025

FDA setback for Sanofi’s Tolebrutinib in progressive MS

Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity


Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets
Drug Approval | December 22, 2025

Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets

Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia


Takeda posts strong Phase 3 win for oral psoriasis drug
Clinical Trials | December 21, 2025

Takeda posts strong Phase 3 win for oral psoriasis drug

Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies