FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on February 8, 2021 - 16:13 GMT

FDA Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive Sleep Apnea in Patients 18 Years and Older

For Immediate Release: February 05, 2021 Today, the U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild obstructive sleep apnea. Unlike devices used while patients sleep, this is the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 8, 2021 - 16:13 GMT

FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma

For Immediate Release: February 05, 2021 Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 8, 2021 - 16:13 GMT

Coronavirus (COVID-19) Update: February 5, 2021

For Immediate Release: February 05, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA has scheduled a meeting of its Vaccines and Related Biological …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 7, 2021 - 15:15 GMT

Coronavirus (COVID-19) Update: July 2, 2021

For Immediate Release: July 02, 2021 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: Today, the FDA authorized the use, under the emergency use authorization (EUA) for the Janssen COVID …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 6, 2021 - 11:09 GMT

FDA Authorizes Marketing of Diagnostic Aid for Autism Spectrum Disorder

For Immediate Release: June 02, 2021 Today, the U.S. Food and Drug Administration authorized marketing of a device to help diagnose autism spectrum disorder (ASD). The Cognoa ASD Diagnosis Aid is a machine learning-based software intended to help health …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 5, 2021 - 15:05 GMT

Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants

For Immediate Release: February 04, 2021 Statement From: Statement Author Leadership Role Acting Commissioner of Food and Drugs - Food and Drug Administration Janet Woodcock M.D. As the public health agency responsible for regulating medical products, we …

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Published on February 5, 2021 - 15:05 GMT

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine ...

For Immediate Release: February 04, 2021 The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 4, 2021 - 17:46 GMT

Coronavirus (COVID-19) Update: April 2, 2021

For Immediate Release: April 02, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Following recent FDA actions to support test development, the FDA took swift …

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Published on February 3, 2021 - 15:52 GMT

Coronavirus (COVID-19) Update: March 2, 2021

For Immediate Release: March 02, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which …

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Published on January 30, 2021 - 21:27 GMT

Coronavirus (COVID-19) Update: January 29, 2021

For Immediate Release: January 29, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: This week, the FDA added a new frequently asked question (FAQ), “Can the FDA …

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Published on January 27, 2021 - 19:23 GMT

Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help ...

For Immediate Release: January 26, 2021 Español As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand sanitizers from …

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Published on January 27, 2021 - 19:23 GMT

Coronavirus (COVID-19) Update: January 26, 2021

For Immediate Release: January 26, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 23, 2021 - 00:21 GMT

Coronavirus (COVID-19) Update: January 22, 2021

For Immediate Release: January 22, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA’s Office of Criminal Investigations recently investigated a case that …

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Published on January 22, 2021 - 00:52 GMT

FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV

For Immediate Release: January 21, 2021 The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in …

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Published on January 20, 2021 - 01:20 GMT

FDA Marks Historic Public Health Milestone with Finalization of Two Key Rules for Companies Seeking to Market New Tobacco Products

For Immediate Release: January 19, 2021 Today, the U.S. Food and Drug Administration finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the …

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Published on January 20, 2021 - 01:20 GMT

Coronavirus (COVID-19) Update: January 19, 2021

For Immediate Release: January 19, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Today, to help protect consumers from methanol poisoning, the FDA issued a …

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Published on January 15, 2021 - 23:35 GMT

Coronavirus (COVID-19) Update: January 15, 2021

For Immediate Release: January 15, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Today, the FDA issued and immediately implemented a new guidance entitled, “ …

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Published on January 15, 2021 - 19:54 GMT

Federal judge enters consent decree against Washington state juice processor

For Immediate Release: January 15, 2021 The U.S. District Court for the Eastern District of Washington entered a consent decree between the U.S. Food and Drug Administration (FDA) and Valley Processing, Inc. of Sunnyside, Washington, along with the company …

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Published on January 15, 2021 - 19:54 GMT

FDA Warns Firms to Remove Unauthorized E-liquid Products from Market in First Letters Issued to Manufacturers that Did Not Submit ...

For Immediate Release: January 15, 2021 Today, the U.S. Food and Drug Administration issued warning letters to 10 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, advising them …

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Published on January 14, 2021 - 22:55 GMT

FDA Grants First Conditional Approval Under Expanded Authority to Control Seizures in Dogs with Idiopathic Epilepsy

For Immediate Release: January 14, 2021 Today, the U.S. Food and Drug Administration granted the first conditional approval under its expanded authority to KBroVet-CA1 (potassium bromide chewable tablets) to control seizures in dogs with idiopathic …

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