An FDA advisory panel concludes that the efficacy of brexpiprazole, when started concurrently with sertraline, has not been ...

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Instil Bio plans to start a phase 1 trial of AXN-2510 for solid tumors following FDA IND clearance. Quiver AI Summary Instil Bio, Inc. announced the clearance of an Investigational New Drug (IND ...

In June 2024, the FDA's Psychopharmacologic Drugs Advisory Committee voted 9-2 against MDMA as an effective treatment for PTSD patients, and 10-1 that the drug's benefits do not outweigh its risks.

Taking MDMA at home doesn’t constitute MDMA-assisted therapy for PTSD, and it can be dangerous, especially if you’re alone.

Lorde says MDMA therapy cured her stage fright. Here's what to know about the controversial mental health treatment.

Unicycive, which was seeking approval of oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease on dialysis, said the FDA issued a so-called complete response ...

SAN FRANCISCO (KPIX) -- With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is frustrated by the delay of approved treatments ...

With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is frustrated by the delay of approved treatments in the rare disease ...

There are currently no FDA-approved therapies for the disease, but Stealth BioTherapeutics has been working for years to get a target drug approved. “Extremely long and delayed,” Megan said.

The FDA has removed the REMS requirements for existing BCMA- and CD19-directed CAR-T therapies and reduced certain other post-infusion restrictions.