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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 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 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,
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.
Everyday Health
2h
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 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
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.
1d
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 ...
92.7 WMAY
8h
FDA approves first 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 ...
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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