Its extensive product portfolio is supported by ANDAs, eCTD Dossiers, and Drug Master Files (DMFs), ensuring compliance with international regulatory requirements. Last checked, the market ...

Breadcrumbs sold for months throughout the United States contain an undeclared allergen and are being recalled for safety reasons, the Food and Drug Administration announced on its website on Jan. 28.

The Food and Drug Administration OK'd 10 Zyn flavors, including coffee, mint and menthol. It's the first time regulators have authorized sales of nicotine pouches, which are the fastest-growing ...

The nasal spray Spravato, which is made from the drug esketamine, had been approved in 2019 for patients who failed to respond to at least two oral antidepressants. However, it had to be used in ...

Companies say they are working to update their products to comply with the Food and Drug Administration's decision Wednesday to ban the artificial food dye Red 3, after the agency said it was ...

Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the standalone treatment of major depressive disorder (MDD), PTSD ...

The petition, first reported by the New York Times, asked the Food and Drug Administration to "revoke Emergency Use Authorizations for existing COVID vaccines and refrain from approving and ...

Jan. 21 (UPI) --The Food and Drug Administration has approved the first-ever stand-alone nasal spray to treat drug-resistant depression. Johnson & Johnson's Spravato has been approved to treat a ...

The U.S. Food and Drug Administration has banned the use of red dye No. 3 in foods, more than three decades after researchers discovered its link to cancer in rodents and to worsened attention deficit ...

The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression ...