The FDA granted approval to Eli Lilly and Company’s mirikizumab-mrkz (Omvoh) for Crohn disease, expanding its treatment reach ...

Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...

FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.

The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...

Because it is still awaiting approval, Medicare does not typically cover the use of ketamine infusion for treating mental ...

In 2021, the FDA approved a new insulin drug, Semglee, that was interchangeable with a brand-name insulin called Lantus.

After a delayed approval, treosulfan’s manufacturer is hopeful the alkylating agent will become the new gold standard in the United States.

The announcement was welcome news for those with major depressive disorder, affecting an estimated 8.3% of the adult ...

The U.S. FDA approved 19 drugs in December, an increase from 10 in November. In total, 228 FDA approvals were granted in 2024, averaging 19 per month. Seven new molecular entities were approved in ...

CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral ...

Spravato is now the first stand-alone therapy for treatment-resistant depression, for patients who haven't responded to oral ...

The FDA has approved a new treatment for patients with a common form of breast cancer that has spread to other parts of the body or cannot be surgically removed.