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Intellia BLA Gets Priority Review for Hereditary Angioedema

[ Price : $8.95]

FDA accepts for priority review an Intellia Therapeutics BLA for lonvo-z, an in vivo CRISPR-based therapy for treating hereditary ...

Krazatis Accelerated Approval for Colorectal Cancer Withdrawn

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FDA acknowledges that Bristol Myers Squibbs accelerated approval of Krazati (adagrasib) in combination with cetuximab for adults w...

FDA Acting Center Directors Made Permanent

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HHS names CDER acting director Michael Davis and CBER acting director Karim Mikhail as permanent directors of their respective off...

FDA Eases Compounding for Neonatal Parenteral Nutrition Drugs

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FDA issues a guidance entitled Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates ...

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...

Ionis Pharmas Alexander Disease Drug Approved

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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...