FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on May 12, 2023 - 18:25 GMT

FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

For Immediate Release: May 12, 2023 Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 12, 2023 - 16:59 GMT

FDA Roundup: December 5, 2023

For Immediate Release: December 05, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, registration opened for the FDA’s virtual Rare Disease Day on Friday, March 1, 2024. This year …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 11, 2023 - 13:35 GMT

FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease

For Immediate Release: May 11, 2023 Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the …

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Published on May 11, 2023 - 13:16 GMT

FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations

For Immediate Release: May 11, 2023 Today, the U.S. Food and Drug Administration finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 9, 2023 - 19:04 GMT

FDA Roundup: May 09, 2023

For Immediate Release: May 09, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA granted marketing authorization of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 …

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Published on May 7, 2023 - 10:38 GMT

FDA, FTC Warn Six Companies for Illegally Selling Copycat Food Products Containing Delta-8 THC

For Immediate Release: July 05, 2023 Today, the U.S. Food and Drug Administration and the Federal Trade Commission issued warning letters to six companies for illegally selling copycat food products containing Delta-8 tetrahydrocannabinol, also known as …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 5, 2023 - 17:50 GMT

FDA Roundup: May 05, 2023

For Immediate Release: May 05, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA issued a safety communication to warn consumers and health care providers to stop …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 28, 2023 - 19:53 GMT

FDA Roundup: April 28, 2023

For Immediate Release: April 28, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a final guidance for industry titled Smoking Cessation and Related Indications: …

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Published on April 26, 2023 - 22:04 GMT

FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides difficile ...

For Immediate Release: April 26, 2023 Today, the U.S. Food and Drug Administration approved Vowst, the first fecal microbiota product that is taken orally. Vowst is approved for the prevention of recurrence of Clostridioides difficile (C. difficile) …

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Published on April 21, 2023 - 19:43 GMT

FDA Roundup: April 21, 2023

For Immediate Release: April 21, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA approved the MiniMed 780G System for modifications to the SmartGuard (SG) Technology and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 18, 2023 - 19:57 GMT

FDA Roundup: April 18, 2023

For Immediate Release: April 18, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA granted marketing authorization to the NTX100 Tonic Motor Activation (NTX100 ToMAc) …

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Published on April 18, 2023 - 13:30 GMT

Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines

For Immediate Release: April 18, 2023 Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. …

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Published on April 17, 2023 - 17:19 GMT

FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation

For Immediate Release: April 17, 2023 Today, the U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white …

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Published on April 14, 2023 - 21:17 GMT

FDA Roundup: April 14, 2023

For Immediate Release: April 14, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued an emergency use authorization (EUA) for the Azure Fastep COVID-19 Antigen Pen …

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Published on April 12, 2023 - 09:04 GMT

FDA, USDA and EPA Propose National Strategy to Reduce U.S. Food Loss and Waste

FDA News Release Public Comment Sought on Draft National Strategy That Aims to Reduce Food Loss and Waste in the U.S. For Immediate Release: December 04, 2023 The U.S. Food and Drug Administration, the U.S. Department of Agriculture (USDA) and the U.S. …

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Published on April 11, 2023 - 18:40 GMT

FDA Roundup: April 11, 2023

For Immediate Release: April 11, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA authorized for marketing the MISHA Knee System, an implant placed alongside the knee …

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Published on April 10, 2023 - 09:20 GMT

FDA Takes Steps to Advance the Development of Novel Therapies for Stimulant Use Disorders

For Immediate Release: October 04, 2023 Today, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders. The guidance, Stimulant Use Disorders: Developing Drugs for …

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Published on April 8, 2023 - 18:49 GMT

FDA Approves First Oral Treatment for Postpartum Depression

For Immediate Release: August 04, 2023 Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs …

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Published on April 8, 2023 - 17:11 GMT

FDA Roundup: August 4, 2023

For Immediate Release: August 04, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a new guidance for immediate implementation, “Recommended Acceptable Intake …

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Published on April 7, 2023 - 20:42 GMT

FDA Roundup: April 7, 2023

For Immediate Release: April 07, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a recall notice about Philips Respironics Recall Certain Reworked DreamStations …

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