The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell lung cancer. The Food and Drug Administration (FDA) has accepted a new drug ...
has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous ...
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA ... Phase 3 clinical trials—RELIEF and ...
GlobalData on MSN6d
Stealth faces another hurdle as FDA delays decision on Barth syndrome drugThe FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults. "There are more than 8 million patients living with schizophrenia in China who face significant ...
The filing was based on a primary analysis of the Phase 2 RAMP 201 clinical trial ... Prescription Drug User Fee Act (PDUFA) date of June 30, 2025, for its New Drug Application (NDA) to the ...
KalVista Pharmaceuticals, Inc. (KALV) announced Tuesday that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted ...
The trial has ... shift from clinical development to a commercial approach for its smoking cessation drug, cytisinicline. The company anticipates a New Drug Application (NDA) for cytisinicline ...
The U.S. Food and Drug Administration (FDA) requested six-month safety exposure data to be included in the company’s planned New Drug Application (NDA ... grateful to the clinical sites ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback