FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on February 18, 2021 - 05:59 GMT

FDA Approves First in the World, First-of-Its-Kind Implant for the Treatment of Rare Bone Disease as a Humanitarian Use Device

For Immediate Release: February 17, 2021 Today, the U.S. Food and Drug Administration approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use. The Patient Specific Talus Spacer is the first in the world and first-of-its- …

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Published on February 17, 2021 - 05:55 GMT

Coronavirus (COVID-19) Update: February 16, 2021

For Immediate Release: February 16, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: As part of the FDA’s effort to protect consumers, the agency issued a …

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Published on February 13, 2021 - 10:34 GMT

FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy

FDA News Release Drug Is Given Before Chemotherapy to Protect Bone Marrow Function For Immediate Release: February 12, 2021 Today, the U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency …

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Published on February 13, 2021 - 10:34 GMT

Coronavirus (COVID-19) Update: February 12, 2021

For Immediate Release: February 12, 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 posted the webpage, COVID-19 Vaccine Safety Surveillance, …

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Published on February 12, 2021 - 11:34 GMT

FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce

For Immediate Release: December 02, 2021 Today, the U.S. Food and Drug Administration issued a proposed rule that aims to enhance the safety of produce. It proposes to require farms to conduct comprehensive assessments that would help them identify and …

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Published on February 11, 2021 - 17:07 GMT

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

For Immediate Release: November 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: Related Information ### Boilerplate The FDA, an agency within the U.S. …

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Published on February 10, 2021 - 02:04 GMT

Coronavirus (COVID-19) Update: February 9, 2021

For Immediate Release: February 09, 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 a Letter to Health Care Providers on Using Ventilator …

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Published on February 9, 2021 - 11:14 GMT

FDA In Brief: FDA Reaches Milestone in Competitive Generic Therapy Drug Approvals

For Immediate Release: September 02, 2021 The following quote is attributed to Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research “This week, the FDA reached the milestone of approving more than …

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Published on February 9, 2021 - 00:00 GMT

FDA Announces New Resource for Veterinarians and Pet Owners Interested in Clinical Field Studies of Animal Cells, Tissues, and ...

For Immediate Release: February 08, 2021 Statement From: Statement Author Leadership Role Director - Center for Veterinary Medicine Steven M. Solomon D.V.M., M.P.H. Veterinary regenerative medicine is a rapidly growing area of product development that …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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: 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 …

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