Friday, the FDA lifted the clinical hold on Biomea Fusion, Inc.’s (NASDAQ:BMEA) ongoing Phase 1/2 clinical trials of the ...

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.

On Thursday, the U.S. Food and Drug Administration approved COBENFY, an oral medication that marks the first new class of ...

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

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 ...

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

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

Dupixent may help some people with inadequately controlled COPD who have a type of lung inflammation that worsens symptoms.

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