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FDA Lifts Hold on Diabetes-Treatment Trials
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,
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 cleared Biomea to study its diabetes drug candidate under a revised protocol intended to mitigate liver toxicity concerns.
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,
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 6.9%. The decision comes as a boon for the company as the regulator placed a hold on two trials of its lead drug,
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.
COPD, Dupixent and FDA
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.
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.
Press Release: Dupixent approved in the US as the first-ever biologic medicine for patients with COPD
Dupixent approved in the US as the first-ever biologic medicine for patients with COPD Dupixent is indicated for the approximately
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.
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 ...
Courthouse News Service
36m
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 ...
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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