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COPD, Dupixent and FDA

Everyday Health · 49m

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.

The Wall Street Journal on MSN · 8h

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.

Business Insider · 9h

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

Hosted on MSN · 1d

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,

FierceBiotech · 12h

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.

MarketWatch · 1d

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,

FDA Approves 1st New Schizophrenia Drug in Decades

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 movement, and sedation — that can cause patients to discontinue treatment.

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.

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 more than 30 years. Cobenfy, manufactured by Bristol Myers

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 Post1d

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.

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.

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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