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The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...
September 27, 2024 at 5:25 PM. New schizophrenia drug gets FDA approval, taking novel approach to treating brain disorder. A new drug has been approved for the treatment of schizophrenia in adults ...
August 22, 2024 at 1:38 PM. (Reuters) -The U.S. Food and Drug Administration said on Thursday it has approved updated COVID-19 vaccines made by Pfizer and Moderna targeting newer variants of the ...
On August 18, 2021, Walensky and acting Commissioner of the FDA Janet Woodcock released a joint statement indicating that, pending FDA approval, booster doses for the Moderna and Pfizer vaccines could become generally available by the week of September 20, for those who had received their second dose at least eight months prior. They stated ...
Amgen. non-small cell lung cancer with KRAS G12C mutation. Avapritinib. Blueprint Medicines Corp. granted for two indications: mast cell leukemia and advanced systemic mastocytosis. Belumosudil. Kadmon Pharmaceuticals. chronic graft-versus-host disease. Pembrolizumab.
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
Loaded 0%. 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 ...
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. ... a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations.