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435 News Found

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


Cosette Pharmaceuticals launches first generic CIPRO HC with 180 Days market exclusivity
Drug Approval | December 20, 2025

Cosette Pharmaceuticals launches first generic CIPRO HC with 180 Days market exclusivity

The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,


Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%
Drug Approval | December 20, 2025

Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%

Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension


Immunome’s Varegacestat shows dramatic results in Phase 3 desmoid tumor trial
Clinical Trials | December 19, 2025

Immunome’s Varegacestat shows dramatic results in Phase 3 desmoid tumor trial

The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival


Novo Nordisk files FDA application for once-weekly obesity drug CagriSema
News | December 19, 2025

Novo Nordisk files FDA application for once-weekly obesity drug CagriSema

If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection


FDA nod to Johnson & Johnson’s AKEEGA for aggressive prostate cancer
Drug Approval | December 18, 2025

FDA nod to Johnson & Johnson’s AKEEGA for aggressive prostate cancer

Patients with BRCA mutations often face aggressive disease and poor prognosis