Insurer access challenges likely lie ahead for the novel schizophrenia drug Cobenfy, given its considerably higher price than ...

The shocking failure of AbbVie’s emraclidine has investors questioning the Big Pharma’s long-term neuroscience strategy, ...

Neuland Labs share price surged after AbbVie’s emraclidine trial setback shifted focus to KarXT. As the exclusive Xanomaline ...

After the recent FDA approval for the promising schizophrenia ... Patients on the drug, also known as KarXT, achieved a 16.9-point reduction on the scale, Zai Lab said. The improvement for those ...

The FDA's proposal comes more than a year after the agency's outside advisers voted against continued use of the ingredient, called oral phenylephrine, citing concerns with the initial data used ...

The FDA's proposal isn't an immediate order; it launches a six-month public comment period, after which the agency will make a final decision on whether to pull it from shelves. In a preemptive ...

Zai Lab (NASDAQ:ZLAB) reported positive topline data from a Phase 3 study in China for KarXT in the treatment of schizophrenia. The FDA approved KarXT for schizophrenia in September. The drug will ...

Specifically, the FDA issued a proposed order to remove oral phenylephrine from the list of drugs that drugmakers can include in over-the-counter products—also known as the OTC monograph.

Kennedy Jr., who is slated to hold a potentially big role in a new Trump administration, said Wednesday there are “entire departments” within the Food and Drug Administration (FDA) that ...

"It is the FDA's role to ensure that drugs are safe and effective," said Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, in a news release on Thursday.

The FDA’s proposal isn’t an immediate order; it launches a six-month public comment period, after which the agency will make a final decision on whether to pull it from shelves. In a ...