The FDA has granted priority review to brensocatib to treat patients with non-cystic fibrosis bronchiectasis, according to a ...

Two senators wrote to the FDA Friday about the Hims Super Bowl ad, which they said misleads patients about compounded weight ...

The FDA approved 16 psychiatric drugs over the last decade, most of which shared similar mechanisms of action with previously ...

The Bridgewater, N.J., biopharmaceutical company said brensocatib has the potential to become the first and only approved treatment for non-cystic fibrosis bronchiectasis, which causes the lungs' ...

The US Food and Drug Administration (FDA) rejected three prior regulatory applications before granting approval.

On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...

The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.

Eton Pharmaceuticals said the Food and Drug Administration has extended by three months its review of the company's application seeking approval of its ET-400 liquid formulation of hydrocortisone.

The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...

Despite high demand for an option like Journavx, doctors fear the drug’s price could be a hangup for insurers and limit ...

Male health supplements have become increasingly important in today's fast-paced world where nutritional gas and lifestyle ...

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...