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FDA Lifts Hold on Diabetes-Treatment Trials
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’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.
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 Fusion : FDA Lifts Clinical Hold On BMF-219 For Type 1 And Type 2 Diabetes Trials; Stock Up
Biomea Fusion Inc. (BMEA) announced that the U.S. Food and Drug Administration has lifted the clinical hold on the company's ongoing
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.
FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials
We greatly appreciate FDA’s review of our data, and the swift resolution of the clinical trial hold. The in-depth review of the clinical data to date reconfirms our confidence in BMF-219 as a novel, first-in-class agent for the treatment of diabetes.
FDA approves a new type of schizophrenia drug
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 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. In November, the
FDA
agreed to review Karuna’s application. The next month, Bristol Myers Squibb announced that it was buying the ...
FDA approves 1st new drug for schizophrenia in more than 30 years
The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with schizophrenia in more than 30 years. Cobenfy, manufactured by Bristol Myers Squibb, combines two drugs,
JD Supra
2h
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 ...
Medscape
6h
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.
Managed Healthcare Executive
3h
FDA Approves Dupixent for Patients with COPD
After a delay, the FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately ...
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 ...
Medscape
3d
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 ...
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