BAVIS_1170X120_10-19-20

FDA

FDA and CDC lift recommended pause on Johnson & Johnson vaccine

FDA and CDC lift recommended pause on Johnson & Johnson vaccine

WASHINGTON — Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be

FDA and CDC call for pause of J&J vaccine over blood clot cases

FDA and CDC call for pause of J&J vaccine over blood clot cases

WASHINGTON — On Tuesday both the Food and Drug Administration and Centers for Disease Control and Prevention  are recommending a “pause” in the administration of Johnson & Johnson’s single-dose COVID-19 vaccine to review blood clot cases. The agencies announced in a statement that the CDC will convene a meeting of the Advisory Committee on Immunization Practices

FDA approves Xolair (omalizumab) prefilled syringe for self-injection across all indications

FDA approves Xolair (omalizumab) prefilled syringe for self-injection across all indications

SOUTH SAN FRANCISCO, Calif.— Genentech announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe

FMI looks forward to working with FDA on “Closer to Zero”

FMI looks forward to working with FDA on “Closer to Zero”

ARLINGTON, Va. – FMI – The Food Industry Association released on Thursday the following statement from chief food and product safety officer Hilary Thesmar, regarding the U.S. Food and Drug Administration’s (FDA) release of a comprehensive plan to outline how the agency will approach heavy metal action levels in baby food. Dr. Thesmar said: “As the

FDA panel endorses Johnson & Johnson vaccine in 22-0 vote

FDA panel endorses Johnson & Johnson vaccine in 22-0 vote

WASHINGTON — The  Food and Drug Administration advisory committee endorsed Johnson & Johnson’s coronavirus vaccine late Friday afternoon, with panel members saying the shot will be a crucial third option to vaccinate millions of Americans. The vaccine appears widely effective against the virus and is especially good at preventing severe cases, according to data presented

FDA clears Moderna vaccine for COVID-19

FDA clears Moderna vaccine for COVID-19

WASHINGTON — The Food and Drug Administration formally authorized a second vaccine for emergency use from Moderna. The biotech upstart won authorization for use in adults following extensive federal analysis of the vaccine, which the FDA found to be 94% effective at preventing the disease. “With the availability of two vaccines now for the prevention of

Panel greenlights Moderna vaccine, paving way for FDA authorization

Panel greenlights Moderna vaccine, paving way for FDA authorization

WASHINGTON — A panel of outside advisers to the U.S. Food and Drug Administration on Thursday endorsed emergency use of Moderna’s coronavirus vaccine, virtually assuring a second option for protecting against COVID-19 for a pandemic ravaged nation. Members of the Vaccines and Related Biological Products Advisory Committee voted 20-0 with one abstention in favor of

FDA authorizes antigen test as first O-T-C fully at-home diagnostic test for COVID-19

FDA authorizes antigen test as first O-T-C fully at-home diagnostic test for COVID-19

WASHINGTON — The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (O-T-C) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments

Today’s FDA panel meeting could lead to Pfizer getting vaccine emergency use okay

Today’s FDA panel meeting could lead to Pfizer getting vaccine emergency use okay

WASHINGTON — Commissioner Stephen Hahn said ahead of  today’s meeting of the Food and Drug Administration’s vaccine advisory panel is “an important day for all of America.” Pfizer’s COVID-19 vaccine faces one last hurdle as it races to become the first shot greenlighted in the U.S. — a panel of experts who will carefully scrutinize

Pfizer seeking emergency use of its COVID-19 vaccine

Pfizer seeking emergency use of its COVID-19 vaccine

NEW YORK  — Pfizer and BioNTech SE announced they will submit a request Friday to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of

Lucira Health’s Rapid Home COVID-19 test gets EUA

Lucira Health’s Rapid Home COVID-19 test gets EUA

WASHINGTON — The FDA has issued an Emergency Use Authorization (EUA) for Lucira Health’s rapid coronavirus test, the first one authorized for self-testing at home and priced at an affordable $50. The molecular single-use test, the All-In-One Test Kit, detects SARS-CoV-2 using self-collected nasal swab samples. Under the EUA, it may be used in the

Abbott’s 15-minute, $5 COVID-19 test gets FDA authorization

Abbott’s 15-minute, $5 COVID-19 test gets FDA authorization

ABBOTT PARK, Ill. — Abbott announced on Wednesday that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results

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