According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.

The FDA has approved Kygevvi (doxecitine and doxribtimine) for the treatment of TK2d in adults and pediatric patients with an age of symptom onset on or before 12 years.

The FDA announced it will relax certain rules for approving low-cost versions of some high-priced medications.

The U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, ...

Treatments for asthma, chronic rhinosinusitis with nasal polyps, dyslipidemia, Cushing syndrome, gonorrhea, HSCT-associated thrombotic microangiopathy, marginal zone lymphoma, motion sickness, ...

The head of the U.S. Food and Drug Administration’s drug division, Dr. George F. Tidmarsh, resigned on November 2, 2025, one ...

New diagnostic kits aim to revolutionize early screening of the disease, potentially allowing patients to receive treatments—such as monoclonal antibodies—sooner.

Ironically enough, his initial downfall had nothing to do with Daraprim. Soon after he became infamous, federal prosecutors ...

Unregulated compounded GLP-1s are not the same as the legitimate medications that doctors prescribe for weight loss and chronic disease management.

The FDA has approved Transcranial Magnetic Stimulation (TMS), a non-drug, magnetic pulse device, for use in teens as young as 15 to treat severe depression.

The FDA approved darolutamide for mHSPC on June 3, [2025], so we now have this in our armamentarium, along with all the other ...