A recalled spinach artichoke dip is a Class II risk, and updates have been issued for the recall of chocolate nut and wafer ...
The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...
Sirolimus, the active ingredient in Felycin-CA1, at a higher dose is used as an immunosuppressant in human patients receiving ...
Trump admin's FDA medical product review units remain protected from cuts, while Marty Makary awaits confirmation as ...
The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.
The FDA told staff on Monday that reviewers of medical products and inspectors of manufacturing facilities cannot take the ...
The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.
Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce ...
Ken Kato, MD, discussed the FDA approval of tislelizumab for the first-line treatment of esophageal squamous cell carcinoma.
Three U.S. senators are calling on Robert Kennedy Jr. to disclose what he and President Trump discussed with drugmakers ...
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Fred Aslan, MD, CEO, Artiva Biotherapeutics, explains what the FDA Fast Track designation for AlloNK in autoimmune diseases means for the acceleration of its development and potential approval of the ...