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FDA Lifts Clinical Hold On BMF-219
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 company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112),
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 type 1 and type 2 diabetes, the drug developer said on Thursday. The regulator had placed a hold on two trials of its lead drug,
Biomea Fusion: FDA Lifts Hold on Diabetes-Treatment Trials
Biomea Fusion said the Food and Drug Administration lifted its clinical hold on continuing clinical trials of the company's diabetes drug. The FDA in June put the biopharmaceutical company's trials on hold,
Biomea upgraded by analysts after FDA lifts clinical hold
Biomea (BMEA) has received two analyst upgrades along with bullish comments from other firms following news the FDA has lifted a clinical hold on a study of its drug BMF-219.
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 experimental drug for type 1 and 2 diabetes, sending its shares up 3.2%. The drug,
FDA, Dupixent and COPD
FDA Approves Dupixent for Some Patients Struggling With COPD Symptoms
Dupixent may help some people with inadequately controlled COPD who have a type of lung inflammation that worsens symptoms.
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 significant reductions in exacerbations and improved lung function in Phase 3 trials.
Regeneron, Sanofi Get FDA OK for Dupixent to Treat COPD
Regeneron Pharmaceuticals and Sanofi have won FDA expanded approval of their blockbuster anti-inflammatory drug Dupixent in chronic obstructive pulmonary disease.
FDA Approves 1st New Schizophrenia Drug in Decades
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 treatment for schizophrenia in decades.
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 movement, and sedation — that can cause patients to discontinue treatment.
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 Drug Administration. Cobenfy (xanomeline/trospium chloride) could bring patients what they've long hoped for: A means of easing the hallucinations and "voices" that disrupt their lives without the weight gain and sluggishness of current dopamine-focused drugs.
Courthouse News Service
39m
Ninth Circuit sides with FDA in oversight of ‘liquid magic’ stem cell therapy
The panel agreed with the FDA that the treatment in which a patient's tissue is processed doesn't fall under the same ...
JD Supra
4h
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 ...
The Washington Post
1d
FDA approves a novel drug for schizophrenia, a potential ‘game changer’
They called their experimental drug KarXT, and shepherded it through clinical
trials
to prove its safety and effectiveness.
Medscape
8h
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.
JD Supra
4d
New FDA clinical trials guidances promote efficient drug development, innovative designs, diversity
The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft ...
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