FDA Press Releases - EIN Presswire - Press Release Distribution Service

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

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

Published on March 30, 2021 - 21:09 GMT

Coronavirus (COVID-19) Update: March 30, 2021

For Immediate Release: March 30, 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 March 30, 2021 - 16:53 GMT

FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test to be Used in More Near-Patient Care Settings

For Immediate Release: March 30, 2021 Today, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, …

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Published on March 27, 2021 - 16:48 GMT

FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma

For Immediate Release: March 27, 2021 The U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 26, 2021 - 20:43 GMT

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

For Immediate Release: March 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: On March 23, 2021, the FDA issued an emergency use authorization (EUA) to the …

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Published on March 26, 2021 - 16:40 GMT

FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease

For Immediate Release: March 26, 2021 Today, the U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT …

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Published on March 26, 2021 - 16:40 GMT

FDA Authorizes Marketing of Device to Improve Gait in Multiple Sclerosis Patients

For Immediate Release: March 26, 2021 Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS). The device is …

Distribution channels: Healthcare & Pharmaceuticals Industry