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Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more ...
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InvestorsHub on MSNAllarity Therapeutics Wins FDA Fast Track Designation for Ovarian Cancer Drug Candidate Stenoparib
Allarity Therapeutics, Inc. (NASDAQ:ALLR) announced Tuesday that the U.S. Food and Drug Administration (FDA) has granted Fast ...
The first few months of 2025 brought hope to the rare disease community. Food and Drug Administration leadership promised ...
The initiative is a response to a Trump administration order to speed the construction of the type of new drug factories many pharmaceutical companies have promised to build.
FDA Establishes April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Comprehensive Data ...
The U.S. Food and Drug Administration has denied approval for PTC Therapeutics' oral medication for a rare genetic disorder ...
Their meetings are subject to strict government transparency rules in terms of scheduling, panel composition and disclosure ...
August 27, 2025Susan C. WincklerChief Executive OfficerReagan-Udall Foundation for the Food and Drug AdministrationWashington, DC 20036 Re: Public Meeting on Demand Forecasting for Controlled ...
The U.S. Food and Drug Administration must quickly restore commonsense guardrails on the abortion pill to safeguard women’s ...
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