FDA Removes Clinical Hold On Biomea Fusion's Early-Stage Trials For Potential Diabetes Candidate
Friday, the FDA lifted the clinical hold on Biomea Fusion, Inc.’s (NASDAQ:BMEA) ongoing Phase 1/2 clinical trials of the ...
US FDA lifts clinical hold on Biomea's diabetes trials after safety review
The U.S. Food and Drug Administration lifted a clinical hold on Biomea Fusion's ongoing studies of its experimental drug for ...
US FDA lifts clinical hold on Biomea's diabetes trials
Biomea Fusion said on Thursday the U.S. Food and Drug Administration lifted a clinical hold on ongoing studies of its ...
Medscape3d
FDA Highlights Concerns Over International Cancer Trials in Draft Guidance
In a proposed guidance, the FDA voiced concerns over whether cancer clinical trials largely or entirely conducted outside the ...
Biomea’s stock bounces back as FDA lifts clinical hold on diabetes trials
The US FDA placed a full clinical hold on two diabetes trials for Biomea’s menin inhibitor after reports of liver toxicity.
Medscape6h
FDA OKs First-in-Class Antipsychotic for Schizophrenia
The FDA has approved a first-in-class antipsychotic that targets cholinergic receptors without blocking dopamine receptors.
FierceBiotech10h
FDA lifts hold on diabetes trials after Biomea mitigates liver toxicity risk
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 ...
Everyday Health22m
FDA Approves the First New Type of Schizophrenia Drug in Decades
Cobenfy doesn’t have the same severe side effects as older schizophrenia medications — like weight gain, involuntary muscle ...
JD Supra2h
FDA Issues Multiple Guidances Supporting Clinical Trial Innovation
In September 2024, the U.S. Food and Drug Administration (FDA) issued three guidance documents to support different clinical ...
FDA Approves Regeneron/Sanofi's Blockbuster Dupixent For Smoker's Lung Disease
The FDA approved Regeneron and Sanofi's Dupixent as an add-on treatment for inadequately controlled COPD, demonstrating ...
FDA Approves Potentially Groundbreaking Schizophrenia Drug
On Thursday, the Food and Drug Administration approved Cobenfy, a drug from Bristol Myers Squibb—the first truly novel ...
HealthDay on MSN4h
FDA Approves New Kind of Drug for Schizophrenia
The first new type of medication in decades to help fight against schizophrenia was approved on Thursday by the U.S. Food and ...