Novo Nordisk said the Food and Drug Administration approved the diabetes-drug Ozempic to be used to help kidney-disease patients. Ozempic, or semaglutide, can now be used to reduce the risk of ...

The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class, with the largest set of specific medical conditions that it may be prescribed to treat.

Please provide your email address to receive an email when new articles are posted on . The FDA approved trastuzumab deruxtecan for a new breast cancer indication. The approval applies to patients ...

The Food and Drug Administration (FDA) has expanded its approval of a ketamine-derived nasal spray, Spravato (esketamine), as a standalone therapy for adults with treatment-resistant depression.

as well as the receipt of regulatory approval from France’s Ministry of Health to initiate a French multi-center study examining the use of Alpha DaRT alongside capecitabine in treating locally ...

Eisai has submitted applications for approval of lecanemab in 17 countries and regions. Additionally, the FDA accepted Eisai's Supplemental Biologics License (BLA) for the LEQEMBI subcutaneous ...

Share on Pinterest The FDA has approved an esketamine nasal spray for the treatment of depression cases that do not respond to other therapeutic approaches. Image credit: Koldunov/Getty Images.

Since the Supreme Court’s Dobbs ruling overturned Roe v. Wade in 2022, Republicans have challenged the FDA’s decadeslong approval of mifepristone as a safe and effective medication for abortion.

Red 3 – also called FD&C Red No. 3, erythrosine or E127 – has been widely used in food, cosmetics and pharmaceuticals since its FDA approval in 1969. You’ve likely encountered Red 3 before.

The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Use the chart below to view import alerts.

Brenner replaces Dr. Robert Califf. The announcement was made quietly via an update made online to the FDA’s leadership bio page. As of Jan. 24 Brenner’s biography had not been added to the page.

The FDA first approved the Johnson & Johnson drug, called Spravato (esketamine), for some cases of depression in 2019, but it was only allowed to be prescribed alongside an oral antidepressant. After ...