FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on March 26, 2021 - 00:13 GMT

FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients

For Immediate Release: March 25, 2021 Today, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 23, 2021 - 22:31 GMT

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

For Immediate Release: March 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: In a March 22 Consumer Update, the FDA provided an update on simple steps to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 22, 2021 - 21:30 GMT

FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief

FDA News Release Products Listing CBD as Inactive Ingredient Cited for Unapproved Drug and Misbranding Violations For Immediate Release: March 22, 2021 The U.S. Food and Drug Administration has issued warning letters to two companies for selling products …

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Published on March 19, 2021 - 21:59 GMT

Coronavirus (COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That ...

FDA News Release Device may be used to identify biomarkers indicative of SARS-CoV-2 infection among certain asymptomatic individuals following a temperature reading that does not meet criteria for fever For Immediate Release: March 19, 2021 Today, the U.S …

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Published on March 19, 2021 - 19:14 GMT

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

For Immediate Release: March 19, 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 16, the FDA posted a new web page on FDA.gov, Screening for COVID-19: …

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Published on March 18, 2021 - 21:13 GMT

FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process

FDA News Release BioFire Respiratory Panel 2.1 is the First COVID-19 Diagnostic Test Granted Marketing Authorization Using the De Novo Review Pathway For Immediate Release: March 17, 2021 Today, the U.S. Food and Drug Administration granted marketing …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 17, 2021 - 00:43 GMT

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

For Immediate Release: March 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: On March 15, 2021, the FDA launched the COVID-19 EUA FDA Adverse Events …

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Published on March 16, 2021 - 19:06 GMT

Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help ...

FDA Statement The following is attributed to Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, and Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 13, 2021 - 00:12 GMT

Coronavirus (COVID-19) Update: March 12, 2021

For Immediate Release: March 12, 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 March 12, 2021 - 14:23 GMT

FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric ...

For Immediate Release: December 03, 2021 Today, the U.S. Food and Drug Administration revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 11, 2021 - 10:19 GMT

FDA In Brief: FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions

For Immediate Release: November 03, 2021 The following quote is attributed to Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health “As technology continues to advance all facets of health care …

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Published on March 9, 2021 - 19:46 GMT

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

For Immediate Release: March 09, 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 Friday, the FDA issued an Emergency Use Authorization (EUA) to Cue Health …

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Published on March 8, 2021 - 15:32 GMT

Coronavirus (COVID-19) Update: August 3, 2021

For Immediate Release: August 03, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: In mid-July, the FDA held a stakeholder call to discuss COVID-19 vaccines, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 6, 2021 - 10:29 GMT

FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain

For Immediate Release: June 03, 2021 The following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance for FDA's Center for Drug Evaluation and Research “Ensuring the quality of prescription drugs and safeguarding the …

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Published on March 6, 2021 - 09:40 GMT

FDA Alerts Health Care Providers to Stop New Implants of Certain Ventricular Assist Device System

For Immediate Release: June 03, 2021 The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System due to a growing body of …

Distribution channels: Healthcare & Pharmaceuticals Industry