The FDA has accepted the New Drug Application for Priority Review for oveporexton in the treatment of narcolepsy type 1.
Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor designed to address the core symptoms of ADHD in children and adults.
A regulatory decision on the application is expected during the fourth quarter of 2024. The Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License ...
Phase 3 trial data show datopotamab deruxtecan reduces the risk of disease progression or death in patients with metastatic TNBC.
The FDA accepted a supplemental biologics license application and granted priority review for Datroway for adults ...
Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the ...
Ever since Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy Elevidys scored its initial approval in a restricted patient population, the company has aimed to expand the drug's ...
The FDA granted Welireg a priority review after it showed promising outcomes for patients with pretreated advanced renal cell carcinoma. The Food and Drug Administration (FDA) granted a priority ...
The Food and Drug Administration (FDA) has granted Priority Review to pegcetacoplan for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC ...
The U.S. FDA has revealed plans to launch a national priority voucher program aimed at reducing the drug review time period for selected manufacturers. The time to review a drug under the program will ...
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