The Latest Breaking News from FDA

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Neffy, the first single-dose nasal spray approved to treat severe allergies, will hit the market in a matter of weeks

Google introduced a new pulse loss detection feature coming to the newly announced Pixel Watch 3 lineup.

Drugmaker Lykos Therapeutics announced on Aug. 9, 2024, that the Food and Drug Administration declined to approve the company’s application for the use of MDMA-assisted therapy in the treatment of post-traumatic stress disorder. It is the first such decision issued on a psychedelic drug application.

There's now an option to treat anaphylaxis via a nasal spray, rather than with an auto-injected medication.

Plus: A listener asks the editors about tariffs and subsidies in the manufacture of electric vehicles.

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The FDA, which approved the protocols for the studies it now questions, is asking for an additional Phase 3 clinical trial, which would take years and millions of dollars.

Ascendis Pharma stock zoomed higher Monday — closing in on a breakout — after the FDA signed off on its embattled hypoparathyroid disease drug.

The Food and Drug Administration declined to approve MDMA as the first psychedelic drug used to treat post-traumatic stress disorder.

The new treatment, a needle-free alternative, could be used for managing severe allergic responses in children and adults, weighing at least 66 pounds, the FDA said.