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Ionis Pharmas Alexander Disease Drug Approved

[ Price : $8.95]

FDA approves Ionis Pharmaceuticals Zanvastro (zilganersen) injection for treating Alexander disease in pediatric and adult patient...

GenAI Devices to See Increased Scrutiny: Law Firm

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A Crowell & Moring analysis says FDA may increase regulatory scrutiny for user-facing GenAI-enabled devices.

FDA Helping to Increase Supply of Estradiol Patches

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FDA says helping to increase supplies of estradiol transdermal patches after reports that some patients are having difficulty find...

Heartvues MRI-Reviewing Software Cleared

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FDA grants Heartvue.ai a 510(k) clearance for its Heartvue.Proton, a machine learningpowered software for viewing, post-processing...

AstraZeneca Wins Accelerated Approval for Breast Cancer Drug

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FDA grants AstraZenenca an accelerated approval for Etcamah (camizestrant), an estrogen receptor antagonist, in combination with a...

Letter Campaign Seeks to Block FDA Commissioner Nominee

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There appears to be growing opposition to FDA commissioner nominee Heidi Overton, as a letter-writing campaign is underway to bloc...

AbbVie Announces Positive Etentamig Data in Multiple Myeloma

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AbbVie announces positive topline results from the Phase 3 CERVINO study evaluating etentamig in patients with triple-class expose...

FDA Strengthening Good Clinical Practice Oversight

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Four FDA senior officials explain how the agency is strengthening its good clinical practice oversight in an increasingly globaliz...

FDA Wants Botanical Drug Development Input

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FDA publishes a request for information on stakeholders views on ways to accelerate botanical drug development.

Study Connection Between Foreign Drug Manufacturing and Recalls

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The Senate Special Committee on Aging chairman and ranking member ask the Government Accountability Office to study and assess any...