FDA

FDA to approve COVID-19 booster shots for immunocompromised people

FDA to approve COVID-19 booster shots for immunocompromised people

NEW YORK— According to published reports, the Food and Drug Administration is expected to approve COVID-19 vaccine booster shots this week. The FDA amendment of the emergency use authorizations for the Pfizer and Modern vaccines would allow anyone with compromised immune systems to get a third dose. The move, which could come as early as today, comes after

NACDS praises FDA approval of interchangeable biosimilar

NACDS praises FDA approval of interchangeable biosimilar

Editor’s note: The National Association of Chain Drug Stores (NACDS) published the following article on their website on the Food and Drug Administration (FDA) approval Semglee as the first interchangeable biosimilar product: In an historic move last week, the Food and Drug Administration (FDA) approved Semglee (insulin glargine-yfgn) as the first interchangeable biosimilar product. With this approval,

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

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