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Questions abound as FDA set to approve updated COVID vaccine

The Food and Drug Administration is expected to approve an updated COVID vaccine, but only for a smaller group of people who ...
BioPharma Dive2d

FDA’s new accelerated pathway may open pharma up to risks, as well as benefits

Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more ...

Grace Therapeutics Announces U.S. Food and Drug Administration Acceptance for Review of New Drug Application for GTx-104

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 ...

Worth the risk: FDA must move more quickly on treatments for rare diseases

The first few months of 2025 brought hope to the rare disease community. Food and Drug Administration leadership promised ...

FDA to start new ‘precheck’ program to boost US drug production

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.
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Allarity 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 ...

US FDA declines to approve PTC Therapeutics' oral drug for rare genetic disorder

The U.S. Food and Drug Administration has denied approval for PTC Therapeutics' oral medication for a rare genetic disorder ...

FDA’s new expert panels are rife with financial conflicts and fringe views

A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules ...

Grace Therapeutics, Inc.: Grace Therapeutics Announces U.S. Food and Drug Administration Acceptance for Review of New Drug Application for GTx-104

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 ...