FDA Press Releases - EIN Presswire - Press Release Distribution Service

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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Published on October 11, 2022 - 18:57 GMT

FDA Roundup: October 11, 2022

For Immediate Release: October 11, 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 announced the launch of an independent study by the National Academies of Sciences, …

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Published on October 1, 2022 - 01:13 GMT

FDA Approves New Treatment Option for Patients with ALS

For Immediate Release: September 29, 2022 The U.S. Food and Drug Administration today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. “This …

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Published on October 1, 2022 - 01:13 GMT

FDA Pathway Supports Long-Term Stability, Diversity of Safe and Nutritious Infant Formula Supply in the U.S.

For Immediate Release: September 30, 2022 Today, the U.S. Food and Drug Administration published guidance that will help provide a pathway for infant formulas operating under enforcement discretion in the U.S. to remain on the market. This will help ensure …

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Published on October 1, 2022 - 01:13 GMT

FDA Roundup: September 30, 2022 

For Immediate Release: September 30, 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 Continues Important Work on Substance Use and Overdose …

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Published on September 28, 2022 - 18:22 GMT

FDA, Veterans Health Administration Collaborate to Help Accelerate Medical Device Innovation and Advancement of Care

For Immediate Release: September 28, 2022 The U.S. Food and Drug Administration and the Veterans Health Administration (VHA) are announcing a collaboration intended to help accelerate American medical device innovation to further improve and benefit public …

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Published on September 28, 2022 - 13:02 GMT

FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease

For Immediate Release: September 28, 2022 Today, the U.S. Food and Drug Administration proposed updated criteria for when foods can be labeled with the nutrient content claim “healthy” on their packaging. This proposed rule would align the definition of …

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Published on September 27, 2022 - 19:41 GMT

FDA Roundup: September 27, 2022

For Immediate Release: September 27, 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 released its Activities to Enhance the Safety of Imported Produce, which provides an …

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