The FDA on Thursday approved a new class of pain medication that provides an alternative to opioids. It will be sold under the brand name Journavx.

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The drug, suzetrigine, received the FDA's official stamp of approval Thursday to be sold as a 50-milligram prescription pill taken every 12 hours, according to a press release. The medication will ...

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Three strikes and you’re out? Not for Supernus Pharmaceuticals and its Parkinson’s disease infusion pump. | The device is ...

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 ...

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 ...

Spravato is the first and only approved monotherapy for adults with refractory major depressive disorder. Approval of Spravato, granted following FDA priority review, was based on the results of a ...

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 ...