US regulators removed a special safety program intended to monitor for certain heart risks with vandetanib (Caprelsa), a drug first approved in 2011 to treat medullary thyroid cancer in patients whose ...

The FDA still recommends prescribers monitor patients’ ANC levels according to the prescribing information. The Food and Drug Administration (FDA) has removed the risk evaluation and mitigation ...

The FDA’s REMS policy, designed to ensure drug safety, is instead harming individuals with treatment-resistant schizophrenia by imposing burdensome requirements on clozapine, the only FDA-approved ...

A recent study found two-thirds of homeless people have a mental illness, with more than three-quarters of them having experienced it during their lifetimes. Between 10 and 20 percent of the homeless ...

In the U.S., schizophrenia remains one of the most severe and debilitating mental health conditions, with effective treatment often out of reach for those who need them most. Clozapine, a medication ...

Homelessness, sadly, is a pervasive problem that persists even in developed countries like the U.S. Two experts say a policy enforced by the Food and Drug Administration (FDA) is making it worse.

On January 4, the Food and Drug Administration (FDA) approved modifications to the Risk Evaluation and Mitigation Strategies (REMS) program for the medication abortion drug mifepristone. These ...

The U.S. Food and Drug Administration removed the Risk Evaluation and Mitigation Strategies (REMS) program for Caprelsa (vandetanib), a thyroid cancer medication manufactured by Sanofi SA’s (NASDAQ: ...

Health care providers will no longer need to do extra monitoring beyond what is expected with standard clinical care. The Food and Drug Administration (FDA) has deemed the Risk Evaluation and ...