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FDA Approves 1st New Schizophrenia Drug in Decades
FDA Approves New Kind of Drug for Schizophrenia
FRIDAY, Sept. 27, 2024 (HealthDay News) -- 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.
FDA approves new type of antipsychotic drug, a potential ‘game changer’
The approval comes less than a year Bristol Myers Squibb paid $14 billion to acquire the developer of the drug, Karuna Therapeutics.
FDA Approves the First New Schizophrenia Drug in Decades
No new treatments for schizophrenia have been approved in nearly three decades, but that changed on Sept. 26, when the U.S. Food and Drug Administration (FDA) approved Cobenfy for the psychiatric disorder.
Sanofi, FDA and Dupixent
Sanofi-Regeneron's Dupixent wins FDA's nod for 'smoker's lung'
The U.S. Food and Drug Administration has approved Sanofi and Regeneron's blockbuster drug Dupixent for patients with a chronic lung disease, commonly known as "smoker's lung", the companies said on Friday.
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.
Sanofi blockbuster drug wins clearance in US for lung disease
Sanofi’s Dupixent has been cleared for a chronic lung disorder in the US, in another milestone for the blockbuster drug after a similar decision by European regulators.
Pfizer, FDA and Oxbryta
FDA alerts patients about Pfizer's Oxbryta withdrawal
The U.S. Food and Drug Administration on Thursday alerted patients and healthcare professionals about the withdrawal of Pfizer's sickle cell disease treatment Oxbryta. Pfizer said late on Wednesday it was pulling the drug from all markets due to risk of a painful complication and death.
What the withdrawal of its sickle cell drug means for Pfizer, patients, and the FDA
European regulators on Thursday also said that patients in the trials had higher rates of the pain crises that are hallmarks of sickle cell disease once they started on Oxbryta, also called voxelotor,
Pfizer to Withdraw Sickle Cell Drug Oxbryta Lots from World-Wide Markets
The healthcare company said clinical data indicates the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population.
FDA Lifts Clinical Hold On BMF-219
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,
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.
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,
MedPage Today
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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 ...
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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 ...
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FDA Approves New Schizophrenia Drug in 70-Year First
The treatment offers hope to thousands of patients who do not respond to existing medications, and has shown promise in treating other neurological disorders.
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FDA’s views on AI are evolving
The guidance is based in part on responses the agency received to a 2023 discussion paper on the topic. The paper received ...
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FDA approves new schizophrenia drug
The U.S. Food and Drug Administration has approved a new drug for adults with schizophrenia, the FDA announced Thursday.
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FDA Warns Recalled Dog Food Should Be 'Thrown Out or Destroyed'
The pet food was found to be contaminated with bacteria that can cause illness and even death in pets and humans.
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FDA approves new type of schizophrenia drug
The U.S. Food and Drug Administration (FDA) on Friday approved a new drug used for treating schizophrenia in adults, ...
Medscape
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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.
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Food and Drug Administration
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