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UPDATE 1-Neurocrine Biosciences' Huntington's disease drug gets FDA approval
Reuters via Yahoo Finance· 3 minutes agoThe U.S. Food and Drug Administration (FDA) has approved the granule formulation of Neurocrine Biosciences' INGREZZA drug to treat movement disorders associated ...
FDA approves Neurocrine Biosciences' Huntington's disease drug
Reuters via Yahoo Finance· 20 minutes agoApril 30 (Reuters) - The U.S. Food and Drug Administration (FDA) has approved granule formulation of Neurocrine Biosciences' drug to treat movement disorders ...
It’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs)...
The National Law Review· 4 hours agoToday, on April 29, 2024, following more than a decade of discourse, the U.S. Food and Drug...
FDA finalizes lab test regulations with more flexibility
Politico· 6 hours agoDiana DeGette (D-Colo.) and Larry Bucshon (R-Ind.) — co-sponsors of legislation known as the VALID Act — said that while they are disappointed with the rule, they “recognize that FDA ...
FDA finalizes rule to increase oversight of lab tests
Boston Herald· 3 hours agoThe rule effectively reclassifies tests developed and performed in a lab as medical devices for the...
Pfizer and Genmab’s Tivdak wins full FDA approval for cervical cancer
Pharmaceutical Technology via Yahoo Finance· 8 hours agoThe BLA was accepted with priority review in April 2021 and approved in September 2021. The FDA’s...
Federal authorities seize more than $700K in illegal e-cigarette products in California
UPI· 3 hours ago"Removing unauthorized tobacco products from the supply chain is one of many enforcement tools we...
FDA Issues Final Rule on Regulation of Laboratory Developed Tests | JD Supra
JD Supra· 15 hours agoApril 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs). This final ruling amends the & ...
FDA Finally Moves to Scrutinize Specialized Health Screenings
ProPublica· 4 hours ago“This is a significant step forward,” said Peter Lurie, president and executive director of the...
Neurocrine Biosciences Announces U.S. FDA Approval of INGREZZA® SPRINKLE (valbenazine) Capsules -...
Benzinga· 39 minutes agoNeurocrine Biosciences, Inc. NBIX today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation ...