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FDA Roundup: May 21, 2024
WTNH-TV New Haven· 3 hours agoThe agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. Either electronic or written comments must be submitted ...
FDA Approves Boehringer Ingelheim’s CYLTEZO® Biosimilar to Humira for Multiple Chronic Inflammatory...
JD Supra· 17 hours agoCYLTEZO was first approved in the US in 2017 and later approved in the US as an interchangeable biosimilar to Humira in October 2021. A lower concentration ...
FDA sets new review date for Halozyme's drug delivery tech By Investing.com
Investing.com· 7 hours agoHalozyme (NASDAQ:HALO) Therapeutics, Inc. (NASDAQ: HALO) announced that the U.S. Food and Drug...
US FDA staff says Guardant's test may fail to detect some pre-cancerous tumors
Reuters via Yahoo News· 10 hours agoThe reviewers, however, said the test may increase compliance with screening for colorectal cancer...
FDA Approves Belimumab Autoinjector for Pediatric Lupus
Medscape· 19 hours agoThis enables at-home administration of the medication, which was previously available only via intravenous infusion.
What's Going On With Colorectal Cancer Diagnostic-Focused Guardant Health Stock On Tuesday?
Benzinga via Yahoo Finance· 3 hours agoTuesday, the FDA's staff reviewers raised concerns regarding Guardant Health Inc's (NASDAQ:GH)...
Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept for Yesafili™. Enters U.S....
WTRF Wheeling· 12 hours agoFood and Drug Administration (US FDA) has approved the Company's first-to-file application for Yesafili™ (aflibercept-jbvf), an interchangeable* biosimilar ...
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 17 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 ...
One year after FDA approves over-the-counter birth control pill, advocates push for more access
Idaho Capital Sun via Yahoo News· 2 days agoStates. “My parents are immigrants from India, and it’s been over the counter there since my mom can...
FDA allows Neuralink to implant 2nd patient with brain chip
FOX 10 Phoenix· 4 hours agoThe Food and Drug Administration has approved Neuralink to implant its brain chip into a second...
