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
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
ICC is a highly aggressive liver cancer arising from the intrahepatic biliary epithelium
Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival
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
Patients with BRCA mutations often face aggressive disease and poor prognosis
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