The U.S. Food and Drug Administration lifted a clinical hold on Biomea Fusion's ongoing studies of its experimental drug for ...

Biomea Fusion said on Thursday the U.S. Food and Drug Administration lifted a clinical hold on ongoing studies of its ...

In a proposed guidance, the FDA voiced concerns over whether cancer clinical trials largely or entirely conducted outside the ...

The US FDA placed a full clinical hold on two diabetes trials for Biomea’s menin inhibitor after reports of liver toxicity.

The FDA has approved a first-in-class antipsychotic that targets cholinergic receptors without blocking dopamine receptors.

Biomea Fusion has escaped from the full clinical hold imposed by the FDA. | Biomea Fusion has escaped from the full clinical hold imposed by the FDA. After reviewing the data, the regulator has ...

Cobenfy doesn’t have the same severe side effects as older schizophrenia medications — like weight gain, involuntary muscle ...

In September 2024, the U.S. Food and Drug Administration (FDA) issued three guidance documents to support different clinical ...

Developed by Karuna Therapeutics, which was subsequently acquired by Bristol Myers Squibb, the drug works in an entirely ...

The first new type of medication in decades to help fight against schizophrenia was approved on Thursday by the U.S. Food and ...

The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft ...

The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with schizophrenia in ...