A new FDA approval stands to give Daiichi Sankyo’s Turalio some company in a rare tumor type. Fellow Japanese drugmaker Ono Pharmaceutical has won an FDA green light for vimseltinib to treat ...

Evrysdi is the only FDA-approved, noninvasive, disease-modifying treatment for spinal muscular atrophy. The tablets offer similar safety and efficacy as the original oral solution. The FDA has ...

Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be approved by the FDA for complicated intra-abdominal infections with limited ...

FDA approves suzetrigine for short-term pain relief Offers opioid-level pain relief without addiction risks First new painkiller mechanism approved in 20+ years ...

A new smart watch which uses machine learning to monitor for the most dangerous kinds of epileptic seizures has been approved by the FDA. Cambridge, Massachusetts based Empatica is the company ...

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.

Lecanemab received full FDA approval in July 2023, becoming the first amyloid beta-directed antibody with such approval. CMS has expanded Medicare coverage for lecanemab following its traditional ...

Regulators have approved the drug as a treatment for weight loss, Type 2 diabetes and lowering the ... [+] risk of heart attacks and strokes. The FDA said Ozempic can be used to reduce the risk of ...

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 ...

Credit: Studio Romantic/Shutterstock. AbbVie has received US Food and Drug Administration (FDA) approval for Emblaveo (aztreonam and avibactam) to be used in conjunction with metronidazole for people ...

The approval was based on results from the phase 3 REVISIT trial. The FDA has approved the intravenous antibiotic Emblaveo for adults with complicated intra-abdominal infections who have limited ...

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.