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 Company has also submitted a New Drug Application ... The NDA submission is supported by previously disclosed results, including data from the KONFIDENT phase 3 clinical trial and ongoing ...
KalVista Pharmaceuticals, Inc. (KALV) announced Tuesday that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted ...
GlobalData on MSN7d
Disc raises $225.5m as it eyes approval of rare skin disorder drugDisc Medicine finalised the pivotal Phase III trial design of bitopertin in erythropoietic protoporphyria (EPP) with the FDA ...
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 ...
Pharmaceuticals announced a streamlined strategic focus on advancing and realizing the potential of apraglutide for the ...
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). Further ... successfully completed two Phase 3 ...
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 ... two Phase 3 clinical trials of ...
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