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US FDA staff says Guardant's test may fail to detect some pre-cancerous tumors
Reuters via Yahoo News· 6 hours agoThe reviewers, however, said the test may increase compliance with screening for colorectal cancer...
FDA sets new review date for Halozyme's drug delivery tech By Investing.com
Investing.com· 2 hours agoHalozyme (NASDAQ:HALO) Therapeutics, Inc. (NASDAQ: HALO) announced that the U.S. Food and Drug...
LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements | JD Supra
JD Supra· 12 hours agoOn May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed ...
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 12 hours agoOn May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration ...
Hims & Hers is selling an Ozempic knockoff without FDA approval. Here's how
Quartz· 1 hour agoThe millennial-skewed telehealth platform Hims & Hers this week joined several online pharmacies in...
FDA grants approval for two Eylea biosimilars for eye conditions
Pharmaceutical Technology via Yahoo Finance· 11 hours agoThe US Food and Drug Administration (FDA) has approved Yesafili (aflibercept-jbvf) and Opuviz...
One year after FDA approves over-the-counter birth control pill, advocates push for more access
Idaho Capital Sun via Yahoo News· 1 day agoStates. “My parents are immigrants from India, and it’s been over the counter there since my mom can...
Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept for Yesafili™. Enters U.S....
WTRF Wheeling· 7 hours agoFood and Drug Administration (US FDA) has approved the Company's first-to-file application for Yesafili™ (aflibercept-jbvf), an interchangeable* biosimilar ...
FDA Grants Withdrawal of Infigratinib for Cholangiocarcinoma
Medscape· 14 hours agoThe US Food and Drug Administration (FDA) has announced the withdrawal of its 2021 accelerated approval of infigratinib (Truseltiq) for patients with a certain type of previously ...
FDA Approves Pivya, a New Treatment for UTIs in Women
Health.com· 1 day agoThe drug, Pivya (pivmecillinam), is approved to treat women over 18 with uncomplicated UTIs, which...