FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on January 4, 2021 - 20:24 GMT

Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase ...

For Immediate Release: April 01, 2021 Today, the U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses per vial for the …

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Published on January 4, 2021 - 18:03 GMT

FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine

For Immediate Release: January 04, 2021 Statement From: Statement Author Leadership Role Acting Director - Center for Drug Evaluation and Research Deputy Center Director for Operations - Center for Drug Evaluation and Research | CDER Patrizia Cavazzoni M.D …

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Published on January 4, 2021 - 11:42 GMT

Coronavirus (COVID-19) Update: FDA Continues to Advance Over-the Counter and Other Screening Test Development

For Immediate Release: March 31, 2021 Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency …

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Published on January 4, 2021 - 11:40 GMT

FDA is Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes

For Immediate Release: April 01, 2021 Today, the U.S. Food and Drug Administration announced it is investigating numerous medical device reports (MDRs) describing patient infections and other possible contamination issues associated with reprocessing …

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Published on January 3, 2021 - 09:26 GMT

FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy

For Immediate Release: March 01, 2021 The U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in certain patients. …

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Published on January 3, 2021 - 08:49 GMT

Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test

For Immediate Release: March 01, 2021 Statement From: Statement Author Leadership Role Director - CDRH Offices: Office of the Center Director Dr. Jeffrey E. Shuren MD, JD Today, the U.S. Food and Drug Administration issued an emergency use authorization ( …

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Published on December 30, 2020 - 22:28 GMT

Coronavirus (COVID-19) Update: December 30, 2020

For Immediate Release: December 30, 2020 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 published a new toolkit to help stakeholders communicate in …

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Published on December 28, 2020 - 23:03 GMT

FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia

For Immediate Release: December 28, 2020 Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which …

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Published on December 28, 2020 - 23:03 GMT

Coronavirus (COVID-19) Update: December 28, 2020

For Immediate Release: December 28, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On Dec. 23, the FDA updated the Device Shortage List on our web page that …

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Published on December 23, 2020 - 23:30 GMT

FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs

For Immediate Release: December 23, 2020 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. While our efforts to combat COVID-19 remain at the forefront of our day-to-day …

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Published on December 23, 2020 - 22:55 GMT

FDA authorizes marketing of new device designed to remove dead pancreatic tissue

For Immediate Release: December 23, 2020 Today, the U.S. Food and Drug Administration authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially …

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Published on December 22, 2020 - 23:33 GMT

Coronavirus (COVID-19) Update: December 22, 2020

For Immediate Release: December 22, 2020 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 has posted translations of the Moderna COVID-19 Vaccine fact sheet …

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Published on December 22, 2020 - 19:52 GMT

FDA Warns Companies Illegally Selling CBD Products

For Immediate Release: December 22, 2020 Today, the U.S. Food and Drug Administration issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). …

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Published on December 21, 2020 - 23:42 GMT

Coronavirus (COVID-19) Update: December 21, 2020

For Immediate Release: December 21, 2020 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 has posted translations of the Pfizer-BioNTech COVID-19 Vaccine fact …

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Published on December 19, 2020 - 00:33 GMT

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

For Immediate Release: December 18, 2020 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome …

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Published on December 18, 2020 - 22:20 GMT

FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer

For Immediate Release: December 18, 2020 Today, the U.S. Food and Drug Administration approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation. …

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Published on December 18, 2020 - 20:02 GMT

FDA Approves Prosthetic Implant for Above-the-Knee Amputations

For Immediate Release: December 18, 2020 The U.S. Food and Drug Administration today approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant system marketed in the U.S. for adults who have …

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Published on December 18, 2020 - 17:49 GMT

FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer

For Immediate Release: December 18, 2020 Today, the U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. “Today’s approval marks the first oral drug in this class and it may …

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Published on December 17, 2020 - 23:36 GMT

Coronavirus (COVID-19) Update: December 17, 2020

For Immediate Release: December 17, 2020 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’s Vaccines and Related Biological Products Advisory Committee …

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Published on December 17, 2020 - 21:55 GMT

Trump Administration Sets the Pace for Food Loss and Waste Reduction Efforts to Continue

For Immediate Release: December 17, 2020 Today, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) announced the renewal of the joint agency formal agreement including the …

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