FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on November 25, 2020 - 20:24 GMT

Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators

For Immediate Release: November 25, 2020 Today, the U.S. Food and Drug Administration (FDA) issued guidance on the use of dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 24, 2020 - 23:31 GMT

Coronavirus (COVID-19) Update: November 24, 2020

For Immediate Release: November 24, 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, an agency within the U.S. Department of Health and Human Services, …

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Published on November 24, 2020 - 00:08 GMT

FDA Approves First Drug to Treat Rare Metabolic Disorder

FDA News Release Approval is for primary hyperoxaluria type 1, which causes recurrent kidney stones and loss of kidney function For Immediate Release: November 23, 2020 Today, the U.S. Food and Drug Administration approved Oxlumo (lumasiran) as the first …

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Published on November 23, 2020 - 23:26 GMT

Coronavirus (COVID-19) Update: November 23, 2020

For Immediate Release: November 23, 2020 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: On Nov. 20, the FDA approved an abbreviated new drug application for succinylcholine chloride …

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Published on November 23, 2020 - 18:13 GMT

FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention

For Immediate Release: November 23, 2020 Today, the U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after …

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Published on November 22, 2020 - 00:58 GMT

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

For Immediate Release: November 21, 2020 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and …

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Published on November 21, 2020 - 00:18 GMT

Coronavirus (COVID-19) Update: November 20, 2020

For Immediate Release: November 20, 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, yesterday, issued an EUA for the drug baricitinib (Olumiant), in …

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Published on November 20, 2020 - 22:55 GMT

FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies

For Immediate Release: November 20, 2020 Today, the U.S. Food and Drug Administration approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford progeria syndrome and for the treatment of certain processing-deficient …

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Published on November 20, 2020 - 22:14 GMT

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

For Immediate Release: November 20, 2020 The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a …

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Published on November 19, 2020 - 21:56 GMT

Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

For Immediate Release: November 19, 2020 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in …

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Published on November 18, 2020 - 20:55 GMT

FDA Releases New Outbreak Investigation Table

FDA Statement New tool will communicate outbreak investigations in early stages For Immediate Release: November 18, 2020 Statement From: Statement Author Leadership Role Deputy Commissioner for Food Policy and Response - Food and Drug Administration Frank …

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Published on November 18, 2020 - 02:52 GMT

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

For Immediate Release: November 17, 2020 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In- …

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Published on November 17, 2020 - 22:59 GMT

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

For Immediate Release: November 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 reaffirmed its commitment to transparency around the EUA …

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Published on November 17, 2020 - 15:22 GMT

COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs

For Immediate Release: November 17, 2020 Statement From: Statement Author Leadership Role Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Emergency use authorizations, or EUAs, are an important tool in our country’s fight …

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Published on November 16, 2020 - 23:38 GMT

Coronavirus (COVID-19) Update: November 16, 2020

For Immediate Release: November 16, 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, FDA updated its guidance on investigational COVID-19 convalescent …

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Published on November 16, 2020 - 18:27 GMT

FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs

For Immediate Release: November 16, 2020 Today, the U.S. Food and Drug Administration approved Stelfonta (tigilanol tiglate injection) to treat dogs with non-metastatic, skin-based (cutaneous) mast cell tumors (MCTs). The FDA is also approving Stelfonta to …

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Published on November 13, 2020 - 22:56 GMT

Coronavirus (COVID-19) Update: November 13, 2020

For Immediate Release: November 13, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: At FDA’s request, the U.S. Department of Justice filed a civil complaint in …

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Published on November 12, 2020 - 23:51 GMT

Coronavirus (COVID-19) Update: November 12, 2020

For Immediate Release: November 12, 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 issued a new Consumer Update urging consumers to avoid …

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Published on October 30, 2020 - 23:28 GMT

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

For Immediate Release: October 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: The FDA, an agency within the U.S. Department of Health and Human Services, …

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Published on October 30, 2020 - 21:35 GMT

FDA, Homeland Security Agencies Take Additional Action to Prevent Import of Illegal and Harmful Medical Products Through ...

For Immediate Release: October 30, 2020 Recently, leadership from the U.S. Food and Drug Administration, the U.S. Customs and Border Protection (CBP), and the U.S. Immigration and Customs Enforcement, Homeland Security Investigations (ICE-HSI) signed a …

Distribution channels: Healthcare & Pharmaceuticals Industry