FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on April 20, 2021 - 17:01 GMT

FDA Announces New Streamlined Approach to Add Pooled Serial Screening Claims to Certain Authorized Tests for Use in Serial Testing ...

For Immediate Release: April 20, 2021 The following quote is attributed to Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health Today, the U.S. Food and Drug Administration took steps to further facilitate the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 16, 2021 - 20:48 GMT

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

For Immediate Release: April 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 warning …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 16, 2021 - 20:48 GMT

Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

FDA News Release Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available For Immediate Release: April 16, 2021 Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 16, 2021 - 16:28 GMT

FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer

For Immediate Release: April 16, 2021 Today, the U.S. Food and Drug Administration approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 14, 2021 - 20:14 GMT

FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19

For Immediate Release: April 14, 2021 The following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D. During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities that manufacture FDA-regulated …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 13, 2021 - 19:24 GMT

Coronavirus (COVID-19) Update: April 13, 2021

Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 13, 2021 - 15:18 GMT

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

FDA Statement The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC For Immediate Release: April 13, 2021 Statement From: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 10, 2021 - 15:55 GMT

Coronavirus (COVID-19) Update: FDA Authorizes Additional OTC Home Test to Increase Access to Rapid Testing for Consumers

FDA Statement The following is attributed to Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health For Immediate Release: October 04, 2021 Statement From: Jeffrey E. Shuren, MD, JD Director - CDRH Offices: Office of the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 10, 2021 - 10:04 GMT

FDA Finalizes Two Foundational Rules for Companies Seeking to Market New Tobacco Products

For Immediate Release: October 04, 2021 Today, the U.S. Food and Drug Administration issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information on the requirements for the content, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 9, 2021 - 23:04 GMT

FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer

FDA News Release Medical device aids clinicians in detecting potential irregularities during colon cancer screening and surveillance For Immediate Release: April 09, 2021 Today, the U.S. Food and Drug Administration authorized marketing of the GI Genius, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 9, 2021 - 19:57 GMT

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

For Immediate Release: April 09, 2021 The U.S. Food and Drug Administration (FDA), today, announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA issued a letter to health care personnel and facilities …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2021 - 18:47 GMT

FDA Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies, Young Children

For Immediate Release: April 08, 2021 Statement From: Statement Author Leadership Role Acting Commissioner of Food and Drugs - Food and Drug Administration Janet Woodcock M.D. Leadership Role Director - Center for Food Safety and Applied Nutrition (CFSAN) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2021 - 12:32 GMT

FDA Participates in New ‘Collaborative Communities’ to Address Emerging Challenges in Medical Devices

For Immediate Release: August 04, 2021 Today, the U.S. Food and Drug Administration announced participation in several new collaborative communities aimed at addressing challenges in patient health care. Collaborative communities are a continuing forum …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 6, 2021 - 20:59 GMT

Coronavirus (COVID-19) Update: April 6, 2021

For Immediate Release: April 06, 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 issued an Emergency Use Authorization (EUA) to Symbiotica, Inc., for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 6, 2021 - 20:59 GMT

FDA Releases Investigation Report Following Fall 2020 Outbreak of E. coli O157:H7 Illnesses Linked to Leafy Greens

For Immediate Release: April 06, 2021 Statement From: Statement Author Leadership Role Deputy Commissioner for Food Policy and Response - Food and Drug Administration Frank Yiannas As part of our ongoing efforts to combat foodborne illness, today the U.S. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 6, 2021 - 17:41 GMT

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test ...

For Immediate Release: April 06, 2021 The U.S. Food and Drug Administration today announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 6, 2021 - 16:32 GMT

FDA Approves First Treatment for Patients with Plasminogen Deficiency, a Rare Genetic Disorder

For Immediate Release: June 04, 2021 Today, the U.S. Food and Drug Administration approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type 1, also referred to as hypoplasminogenemia, a disorder that can …

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Published on April 6, 2021 - 15:45 GMT

Coronavirus (COVID-19) Update: June 4, 2021

For Immediate Release: June 04, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On June 1, the FDA approved an abbreviated new drug application for albuterol …

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Published on April 6, 2021 - 14:17 GMT

FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014

For Immediate Release: June 04, 2021 Today, the U.S. Food and Drug Administration approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition ( …

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Published on April 5, 2021 - 15:45 GMT

Coronavirus (COVID-19) Update: May 4, 2021

For Immediate Release: May 04, 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 Center for Drug Evaluation and Research (CDER) continually monitors our …

Distribution channels: Healthcare & Pharmaceuticals Industry