FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on November 17, 2022 - 22:13 GMT

FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes

For Immediate Release: November 17, 2022 Today, the U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 17, 2022 - 16:13 GMT

FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular Disease

For Immediate Release: November 17, 2022 Today, the U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related …

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Published on November 16, 2022 - 18:38 GMT

FDA Spurs Innovation for Human Food from Animal Cell Culture Technology

For Immediate Release: November 16, 2022 Statement From: Robert M. Califf, M.D., MACC Commissioner of Food and Drugs - Food and Drug Administration Susan T. Mayne, Ph.D. Director - Center for Food Safety and Applied Nutrition (CFSAN) The world is …

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Published on November 16, 2022 - 17:09 GMT

FDA Warns Firms for Selling Illegal E-cigarettes That Look Like Toys, Food, and Cartoon Characters

FDA News Release Companies Must Stop Marketing Unauthorized Products or Risk Enforcement For Immediate Release: November 16, 2022 Today, the U.S. Food and Drug Administration issued warning letters to five firms for the unauthorized marketing of 15 …

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Published on November 15, 2022 - 19:53 GMT

FDA Mengalami Kemajuan di Era Baru Keamanan Pangan yang Lebih Cerdas, Memfinalisasi Aturan Dasar untuk Meningkatkan Keterlacakan ...

For Immediate Release: November 15, 2022 English Hari ini, Badan Pengawas Obat dan Makanan AS mengumumkan kemajuan yang belum pernah terjadi sebelumnya dalam pencegahan penyakit yang ditularkan melalui makanan melalui finalisasi aturan untuk melacak …

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Published on November 15, 2022 - 19:22 GMT

FDA Roundup: November 15, 2022

For Immediate Release: November 15, 2022 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) to Roche Molecular Systems, Inc. for the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 15, 2022 - 17:24 GMT

FDA Advances the New Era of Smarter Food Safety, Finalizing Foundational Rule to Improve Traceability of Contaminated Foods

For Immediate Release: November 15, 2022 Today, the U.S. Food and Drug Administration announced an unprecedented advancement in foodborne illness prevention through the finalization of a rule to more effectively trace contaminated food through the food …

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Published on November 15, 2022 - 16:00 GMT

FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-...

FDA News Release Agency Continues to Encourage Sponsor Applications for Over-the-Counter Naloxone Products For Immediate Release: November 15, 2022 Agency Continues to Encourage Sponsor Applications for Over-the-Counter Naloxone Products Today, the U.S. …

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Published on November 15, 2022 - 16:00 GMT

FDA Conditionally Approves First Drug to Manage Acute Onset of Pancreatitis in Dogs

For Immediate Release: November 15, 2022 Today, the U.S. Food and Drug Administration conditionally approved Panoquell-CA1 (fuzapladib sodium for injection) for the management of clinical signs associated with acute onset of pancreatitis in dogs. Panoquell …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 14, 2022 - 22:07 GMT

FDA Infant Formula Update: November 14, 2022

For Immediate Release: November 14, 2022 Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s increased flexibilities. Company ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 28, 2022 - 20:44 GMT

FDA Roundup: October 28, 2022

For Immediate Release: October 28, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA updated the list of Breakthrough Devices that have been authorized for marketing. The …

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Published on October 26, 2022 - 16:35 GMT

FDA Denies Marketing of Logic’s Menthol E-Cigarette Products Following Determination They Do Not Meet Public Health Standard

For Immediate Release: October 26, 2022 Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic). The currently marketed products …

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Published on October 25, 2022 - 21:13 GMT

FDA Roundup: October 25, 2022

For Immediate Release: October 25, 2022 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 Safety Communications warning consumers, caregivers and health care …

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Published on October 24, 2022 - 21:15 GMT

La FDA busca prohibiciones judiciales permanentes contra seis fabricantes de cigarrillos electrónicos

For Immediate Release: October 17, 2022 English Hoy, el Departamento de Justicia (DOJ, por sus siglas en inglés), en nombre de la Administración de Alimentos y Medicamentos de EE. UU., solicitó prohibiciones permanentes en los tribunales federales de …

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Published on October 21, 2022 - 21:52 GMT

FDA Roundup: October 21, 2022

For Immediate Release: October 21, 2022 FDA Roundup: October 21, 2022 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 draft guidance, “Select Updates for the …

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Published on October 18, 2022 - 22:25 GMT

FDA Roundup: October 18, 2022

For Immediate Release: October 18, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Tuesday, the FDA issued an emergency use authorization (EUA) for the first over-the-counter …

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Published on October 18, 2022 - 19:07 GMT

FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers

For Immediate Release: October 18, 2022 Today, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers. These …

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Published on October 17, 2022 - 13:09 GMT

FDA Awards 19 Grants and Two Contracts Related to Rare Diseases, including ALS

For Immediate Release: October 17, 2022 Today, the U.S. Food and Drug Administration announced it has awarded 19 new grants and two new contracts totaling more than $38 million in funding over the next four years to support clinical trials, natural history …

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Published on October 14, 2022 - 20:09 GMT

FDA Roundup: October 14, 2022

For Immediate Release: October 14, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “FDA Seeks Feedback on Distributed and Point-of-Care Drug …

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Published on October 12, 2022 - 14:16 GMT

Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in ...

For Immediate Release: October 12, 2022 Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a …

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