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Topic: FDA Approval

Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE™ (setmelanotide) as First-ever Therapy for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency

This week, Rhythm Pharmaceuticals, a biopharmaceutical company specializing in the treatment of rare genetic diseases surrounding obesity, announced the U.S. […]

Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE™ (setmelanotide) as First-ever Therapy for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency
3 months ago
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Remdesivir’s Sordid Regulatory History Calls Efficacy into Question

On October 28, Science Magazine took a look at the arguably sordid regulatory history of Gilead Sciences’ remdesivir. On October 8, Gilead […]

Remdesivir’s Sordid Regulatory History Calls Efficacy into Question
4 months ago
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Gilead’s Remdesivir (Veklury®) Approved by FDA for Treatment of Hospitalized COVID-19 Patients

Gilead Sciences, Inc. (Nasdaq: GILD) recently announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug […]

Gilead’s Remdesivir (Veklury®) Approved by FDA for Treatment of Hospitalized COVID-19 Patients
4 months ago
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FDA Approves First Drug Treatment of Peanut Allergy for Children

The U.S. Food and Drug Administration approved Aimmune Therapeutics’ Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to mitigate allergic reactions, including anaphylaxis, that may […]

FDA Approves First Drug Treatment of Peanut Allergy for Children
1 year ago
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FDA Approves Lemborexant (Dayvigo) for Insomnia Disorder—A Growing Problem

Dayvigo (lemborexant), developed and sponsored by Eisai, was approved by the Food and Drug Administration (FDA) for the treatment of […]

FDA Approves Lemborexant (Dayvigo) Approved for Insomnia Disorder—A Growing Problem
1 year ago
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An Approved Cystic Fibrosis Drug and Point of View from Nebraska in the Heartland of America

2019 was a promising year for cystic fibrosis (CF) patients as a new drug called Trikafta was approved by the […]

An Approved Cystic Fibrosis Drug and Point of View from Nebraska in the Heartland of America
1 year ago
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Gustave Roussy & Paris-Sud University Develops AI Program That can Predict Cancer Drug Approval

Gustave Roussy Institute and Paris-Sud researchers and engineers have developed an artificial intelligence system called Resolved2. The program has been […]

Gustave Roussy & Paris-Sud University Develops AI Program that can Predict Cancer Drug Approval
1 year ago
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FDA Approves First Oral GLP-1 Treatment for Type 2 Diabetes, but not Without Stipulations

Unique directions for taking first oral GLP-1 may cause a compliance issue; it’s not as simple as just taking a […]

FDA Approves First Oral GLP-1 Treatment for Type 2 Diabetes, but not Without Stipulations
1 year ago
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Biogen Announces Pursual of FDA Approval for Aducanumab

Biogen and its Japanese partner Eisai announced Oct. 22nd an unexpected reversal—pharmaceutical giant Biogen said it will pursue US Food […]

Biogen Announces Pursual of FDA Approval for Aducanumab
1 year ago
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FDA Grants Breakthrough Status for First-Ever Treatment for Lupus Nephritis Called Gazvya

The U.S. Food and Drug Administration granted breakthrough therapy designation of obinutuzumab (Gazyva) for lupus nephritis, major morbidity of systemic […]

1 year ago
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