FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on May 5, 2021 - 17:41 GMT

Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of ...

For Immediate Release: May 05, 2021 Today, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 30, 2021 - 21:39 GMT

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

For Immediate Release: April 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: On April 28, the FDA approved an abbreviated new drug application (ANDA) for 23 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 30, 2021 - 20:56 GMT

FDA Approves Treatment for Chronic Kidney Disease

FDA News Release Approval is First to Cover Many Causes of Disease For Immediate Release: April 30, 2021 Today, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 30, 2021 - 20:53 GMT

La FDA se compromete a tomar medidas basadas en la evidencia dirigidas a salvar vidas y prevenir futuras generaciones de fumadores

For Immediate Release: April 29, 2021 English Hoy, la Administración de Alimentos y Medicamentos de los EE.UU. (FDA, por sus siglas en inglés) anunció que se compromete a avanzar en el desarrollo de dos normas para productos del tabaco y reducir …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 30, 2021 - 13:45 GMT

FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose

For Immediate Release: April 30, 2021 The U.S. Food and Drug Administration announced today the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) of naloxone …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 29, 2021 - 14:22 GMT

FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers

For Immediate Release: April 29, 2021 Today, the U.S. Food and Drug Administration announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products, the leading cause of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 28, 2021 - 17:27 GMT

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov

For Immediate Release: April 28, 2021 Statement From: Statement Author Leadership Role Acting Commissioner of Food and Drugs - Food and Drug Administration Janet Woodcock M.D. Being transparent about the results of completed clinical trials enables …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 27, 2021 - 19:15 GMT

Coronavirus (COVID-19) Update: April 27, 2021

For Immediate Release: April 27, 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 23, 2021 - 23:08 GMT

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

FDA News Release Agencies Underscore Confidence in Vaccine’s Safety and Effectiveness Following Data Assessment; Available Data Suggest Potential Blood Clots Are Very Rare Events For Immediate Release: April 23, 2021 Following a thorough safety review, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 23, 2021 - 20:19 GMT

Coronavirus (COVID-19) Update: April 23, 2021

For Immediate Release: April 23, 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 agency’s regulatory processes for reviewing all manufacturing …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 23, 2021 - 15:22 GMT

FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients

For Immediate Release: April 23, 2021 Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 22, 2021 - 17:52 GMT

FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker

FDA News Release Approval is for recurrent or advanced mismatch repair deficient (dMMR) endometrial cancer For Immediate Release: April 22, 2021 Today, the U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 21, 2021 - 13:32 GMT

FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines

For Immediate Release: April 21, 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 Biologics Evaluation and Research (CBER) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 20, 2021 - 19:26 GMT

Coronavirus (COVID-19) Update: April 20, 2021

For Immediate Release: April 20, 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 took steps to further facilitate the authorization of tests for …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

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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, …

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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