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US FDA staff says Guardant's test may fail to detect some pre-cancerous tumors
Reuters via AOL· 2 hours agoThe reviewers, however, said a benefit would be that the test may increase compliance with screening...
FDA grants approval for two Eylea biosimilars for eye conditions
Pharmaceutical Technology via Yahoo Finance· 7 hours agoThe US Food and Drug Administration (FDA) has approved Yesafili (aflibercept-jbvf) and Opuviz...
LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements | JD Supra
JD Supra· 9 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 ...
One year after FDA approves over-the-counter birth control pill, advocates push for more access
Idaho Capital Sun via Yahoo News· 1 day ago“My parents are immigrants from India, and it’s been over the counter there since my mom can...
FDA Approves Pivya, a New Treatment for UTIs in Women
Health via Yahoo News· 24 hours agoIs Pivya—and How Effective Is it? Pivya is a synthetic version of penicillin that’s been used in...
FDA Approves First Interchangeable Biosimilars to Aflibercept for AMD
MedPage Today· 1 day agoThe FDA approved the first interchangeable biosimilars to aflibercept (Eylea) to treat macular degeneration, according to an announcement from the agency ...
US FDA approves two biosimilars for blockbuster eye drug Eylea
Reuters via Yahoo News· 1 day agoThe agency approved Biocon Biologics' Yesafili as well as Samsung Bioepis and Biogen's Opuviz, while...
FDA approves lung cancer treatment
CW39 NewsFix· 15 hours ago(KIAH) – Lung Cancer is a complex and devastating disease with over 200,000 new cases in 2024 alone. Small Cell Lung Cancer, or SCLC, is one of the most aggressive cancers out there, reportin…
FDA approves self-collection screening for virus that causes cervical cancer
U-T San Diego· 4 hours agoThe Food and Drug Administration this week moved to expand screening for potentially lethal cervical cancer by allowing women to collect test samples themselves, a move that reproductive health ...
FDA Grants Withdrawal of Infigratinib for Cholangiocarcinoma
Medscape· 11 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 ...
