When the Food and Drug Administration needs outside guidance, it normally turns to a trusted source: a large roster of expert ...

The U.S. Food and Drug Administration has approved the ketamine product, KETARx, for use in surgical pain management.

The FDA’s recent issue of five warning letters to brands illegally marketing whipped, mousse and foam sunscreen products ...

After a more than decadelong process to bring the experimental drug elamipretide to market, the treatment’s approval has ...

US regulators sent seemingly mixed messages this month about the outlook for animal-derived, or desiccated, thyroid medicines ...

The FDA said in letters to five sunscreen makers that they are not authorized to market sunscreen sold in mousse or whipped form.

Wegovy is the first GLP-1 drug approved to treat adults with metabolic dysfunction-associated steatohepatitis (MASH). An ...

The glucagon-like peptide-1 (GLP-1) receptor agonist gained accelerated approval for patients with MASH and moderate to ...

Sublingual cyclobenzaprine (Tonmya), a nonopioid treatment for adults with fibromyalgia, targets nonrestorative sleep, a root ...

Sarepta Therapeutics has provided additional safety data on its gene therapy Elevidys as a Duchenne muscular dystrophy ...

Tonmya is the first new fibromyalgia treatment approved by the FDA in more than 15 years, providing symptom relief for at ...

Robert F. Kennedy Jr. has said the CDC's vaccine advisory board was rife with conflicts of interest. A new analysis shows ...