FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on January 24, 2022 - 21:56 GMT

Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant

FDA Statement The following is attributed to Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research For Immediate Release: January 24, 2022 Statement From: Patrizia Cavazzoni, M.D. Director - Center for Drug Evaluation and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 22, 2022 - 00:14 GMT

FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19

For Immediate Release: January 21, 2022 Today, the U.S. Food and Drug Administration took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 21, 2022 - 19:43 GMT

FDA Roundup: January 21, 2022

For Immediate Release: January 21, 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 two FY 2022 funding opportunities that could provide up to $800,000 in support …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 18, 2022 - 21:17 GMT

FDA Roundup: January 18, 2022

For Immediate Release: January 18, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: The CDRH Health of Women Program Strategic Plan is now available. CDRH initially issued a proposed …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 18, 2022 - 15:14 GMT

FDA Releases CDRH Health of Women Strategic Plan to Better Inform Medical Device Research and Regulation for All Women

FDA Statement The following is attributed to Terri Cornelison, M.D., Ph.D., Chief Medical Officer and Director, Health of Women Program at FDA Center for Devices and Radiological Health For Immediate Release: January 18, 2022 Statement From: Today, as part …

Distribution channels:

Published on January 14, 2022 - 19:27 GMT

FDA Roundup: January 14, 2022

For Immediate Release: January 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 Interagency Food Safety Analytics Collaboration — a collaboration between the Centers for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 13, 2022 - 16:32 GMT

FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic ...

For Immediate Release: January 13, 2022 Today, the U.S. Food and Drug Administration released a white paper developed by the Interagency Working Group on Asbestos in Consumer Products (IWGACP) that contains scientific opinions for the testing of talc- …

Distribution channels:

Published on January 13, 2022 - 15:50 GMT

FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal ...

For Immediate Release: January 13, 2022 Today, the U.S. Food and Drug Administration approved Solensia (frunevetmab injection), the first treatment for the control of pain associated with osteoarthritis in cats and the first monoclonal antibody (mAb) new …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 11, 2022 - 22:28 GMT

FDA Roundup: January 11, 2022

For Immediate Release: January 11, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Jan. 10, the FDA announced in a letter of enforcement discretion that it does not intend to object …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 11, 2022 - 16:55 GMT

FDA Roundup: November 1, 2022

For Immediate Release: November 01, 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 proposed rule to amend the color additive regulations to increase the fees …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 7, 2022 - 21:59 GMT

FDA Roundup: January 7, 2022

For Immediate Release: January 07, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Jan. 5, the FDA published a new, interactive public data dashboard that allows anyone to view …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 7, 2022 - 14:33 GMT

Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months

For Immediate Release: January 07, 2022 Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 7, 2022 - 11:53 GMT

FDA Roundup: July 1, 2022

For Immediate Release: July 01, 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 a request for nominations for consumer representatives to serve on advisory …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 5, 2022 - 00:26 GMT

FDA Roundup: January 4, 2022

For Immediate Release: January 04, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Dec. 21, the FDA published the webpage: Wastewater Surveillance for SARS-CoV-2 Variants describing …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 4, 2022 - 15:11 GMT

FDA Roundup: April 1, 2022

For Immediate Release: April 01, 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: “Give Your Community a Boost: Combatting Misinformation Through …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 3, 2022 - 16:00 GMT

FDA Roundup: March 1, 2022

For Immediate Release: March 01, 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 communication warning people not to use the Celltrion DiaTrust COVID-19 Ag …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 3, 2022 - 14:51 GMT

Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

For Immediate Release: January 03, 2022 Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to: Expand the use of a single booster dose to include use in individuals 12 through …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 3, 2022 - 10:55 GMT

FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments

FDA News Release FDA’s Industry Recommendations and Cancer Moonshot Aim to Improve Lives of Patients and Their Families For Immediate Release: March 01, 2022 Today, the U.S. Food and Drug Administration issued three final guidances to industry regarding …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 2, 2022 - 16:38 GMT

Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 ...

For Immediate Release: February 01, 2022 Today, the U.S. Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the request for emergency use …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 2, 2022 - 15:53 GMT

FDA Roundup: February 1, 2022

For Immediate Release: February 01, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Jan. 31, the FDA released a new video that provides an overview of the 2021 Food Allergy Safety, …

Distribution channels: Healthcare & Pharmaceuticals Industry