Johnson & Johnson (NYSE:JNJ) announced today that the FDA granted priority review to a new drug application (NDA) for its TAR-200.

The Food and Drug Administration (FDA) has accepted for review the second resubmitted New Drug Application (NDA) for reproxalap for the treatment of the signs and symptoms of dry eye disease.

Perre Fabre Pharmaceuticals, Inc. Announces Transfer of Investigational New Drug Application for Tabelecleucel from Atara Biotherapeutics, Inc.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism.

Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer ...

Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic ...

An FDA advisory panel will meet July 18 to consider a supplemental new drug application for the antipsychotic brexpiprazole, in combination with sertraline, for the treatment of PTSD.

U.S. FDA Accepts New Drug Application for Merck’s DOR/ISL Once-Daily Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1.

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 ...

Decitabine/cedazuridine plus venetoclax met its primary endpoint with a complete response rate of 46.5%. The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application ...