The FDA has accepted a new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian ...

Corcept Therapeutics ( ($CORT) ) just unveiled an announcement. On September 10, 2025, Corcept Therapeutics announced that the FDA has accepted ...

The U.S. Food and Drug Administration (FDA) has approved the New Drug Application, or NDA, for Camcevi ETM (leuprolide mesylate 21 milligrams), a ready-to-use long-acting injectable (LAI) formulation ...

Alphamab Oncology (Stock Code: 9966.HK) announced that the New Drug Application (NDA) for anbenitamab injection (KN026), independently developed by the Company and co-developed with JMT-Bio Technology ...

“Given the strong growth outlook for the company’s ex-Humira portfolio, particularly for Skyrizi and Rinvoq, we expect shares ...

NEW HAVEN, Conn., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today with its partner Pfizer Inc. (NYSE: PFE), announced that the U.S. Food and Drug Administration (FDA) has ...

The FDA is moving to scale back its long-standing use of expert panels to review drug applications, KFF Health News reported Sept. 12. George Tidmarsh, MD, PhD, director of the FDA’s Center for Drug ...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New ...

Submission Has the Potential to Trigger Exercise of up to $7.6 million in Gross Proceeds from 2023 Financing Warrants Tied to FDA Acceptance of NDA for Review The FDA typically has a 60-day period to ...

One of the major deficiencies was CBA Pharma failed to establish the drug’s efficacy for its intended use to enhance ...

Syndax Pharmaceuticals was given priority review by the Food and Drug Administration for its supplemental new drug application for Revuforj. Revuforj is designed to treat patients with relapsed or ...

U.S. FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1 Infection ...