FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on June 15, 2021 - 19:11 GMT

FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns

For Immediate Release: June 15, 2021 Today, the U.S. Food and Drug Administration approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 11, 2021 - 20:15 GMT

Coronavirus (COVID-19) Update: June 11, 2021

For Immediate Release: June 11, 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 10, the FDA issued a safety communication warning the public to stop …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 11, 2021 - 15:55 GMT

FDA Takes Steps to Increase Availability of COVID-19 Vaccine

For Immediate Release: June 11, 2021 Following careful review and deliberation, the U.S. Food and Drug Administration is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 10, 2021 - 11:25 GMT

FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs

For Immediate Release: October 06, 2021 Statement From: Donald D. Ashley, J.D. Director - Office of Compliance Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug. The FDA is continuing our …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 9, 2021 - 15:57 GMT

FDA In Brief: FDA Provides Guidance on Measuring Patient-Reported Outcomes in Cancer Clinical Trials

For Immediate Release: June 09, 2021 The following quote is attributed to Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 8, 2021 - 20:47 GMT

Coronavirus (COVID-19) Update: June 8, 2021

For Immediate Release: June 08, 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 White House, the U.S. Department of Health and Human Services (HHS) Office …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 8, 2021 - 17:10 GMT

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

For Immediate Release: August 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: Today, FDA announced that it has found certain lots of Astra Zeneca COVID-19 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 8, 2021 - 10:35 GMT

FDA Approves New Treatment for Pompe Disease

For Immediate Release: August 06, 2021 Today, the U.S. Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of age and older with late-onset Pompe disease. Patients with Pompe …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 7, 2021 - 15:57 GMT

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

For Immediate Release: July 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: On Thursday, June 29, 2021, Acting FDA Commissioner Janet Woodcock, M.D. and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 7, 2021 - 15:43 GMT

FDA Grants Accelerated Approval for Alzheimer’s Drug

For Immediate Release: June 07, 2021 Today, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 28, 2021 - 19:55 GMT

Coronavirus (COVID-19) Update: May 28, 2021

For Immediate Release: May 28, 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, FDA released the Medical Countermeasures Initiative (MCMi) Program …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 28, 2021 - 19:04 GMT

FDA Seeks $6.5 Billion to Further Investments in Critical Public Health Infrastructure, Core Food Safety and Medical Product ...

FDA News Release Fiscal Year 2022 Budget Request Reflects Nearly 8% Increase from Previous Year and Focuses on Agency’s Immediate Priorities For Immediate Release: May 28, 2021 The U.S. Food and Drug Administration is requesting a total budget of $6.5 …

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Published on May 28, 2021 - 17:19 GMT

FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy

For Immediate Release: May 28, 2021 Today, the U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 26, 2021 - 22:28 GMT

Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19

For Immediate Release: May 26, 2021 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 26, 2021 - 17:53 GMT

FDA, FTC Warn Five Companies Illegally Selling Dietary Supplements Claiming to Treat Infertility

For Immediate Release: May 26, 2021 Today, the U.S. Food and Drug Administration and the Federal Trade Commission issued warning letters to five companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent infertility …

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Published on May 26, 2021 - 13:54 GMT

FDA In Brief: FDA Announces Draft Guidances to Help Increase Transparency, Assist Reporting and Timely Completion for Certain ...

For Immediate Release: May 26, 2021 The following quote is attributed to William Maisel, M.D., chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health: “Today, the FDA issued …

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Published on May 25, 2021 - 20:43 GMT

Coronavirus (COVID-19) Update: May 25, 2021

For Immediate Release: May 25, 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 updated its guidance, Emergency Use Authorization for Vaccines to …

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Published on May 21, 2021 - 21:48 GMT

FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom

For Immediate Release: May 21, 2021 The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized more than 207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including …

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Published on May 21, 2021 - 21:00 GMT

Coronavirus (COVID-19) Update: May 21, 2021

For Immediate Release: May 21, 2021 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: The FDA issued a reminder to health care providers to give clear, step-by-step instructions to …

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Published on May 21, 2021 - 17:01 GMT

FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

For Immediate Release: May 21, 2021 Today, the U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: …

Distribution channels: Healthcare & Pharmaceuticals Industry