First approved in 1989, clozapine is the only medication indicated for treatment-resistant schizophrenia. It's also indicated ...

If the FDA follows an advisory committee’s vote, it can potentially be a transformative step in the delivery of mental health ...

A new FDA approval stands to give Daiichi Sankyo’s Turalio some company in a rare tumor type. | The new FDA approval gives ...

It is available only through a restricted REMS program. The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as monotherapy for adults ...

However, Spravato remains restricted under the FDA's REMS program due to its abuse potential. Investors will watch how this regulatory win impacts Johnson & Johnson's pharma segment ahead of earnings.

It was also decided that henceforth, if any drug with inpatient-applicable REMS ... available in case of an audit by the APPRISE program. REMS requirements for ESAs also stipulate that patients ...

The FDA has approved Johnson & Johnson’s (J&J ... the treatment is available only through the Spravato REMS program. Common AEs include temporary increased blood pressure; issues with thinking clearly ...

Spravato is classified as a Schedule III controlled substance and is only available through a restricted program called the Spravato REMS. The Food and Drug Administration (FDA) has approved ...

Heart failure may cause symptoms such as: Due to the risk of heart failure, Camzyos is available through a risk evaluation and mitigation strategies (REMS) program only. The FDA requires REMS ...

Morgan Stanley analyst Jeffrey Hung upgraded Cytokinetics (CYTK) to Overweight from Equal Weight with a price target of $67, down from $70. The ...