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Human Drugs

Hold Removed on vTv Therapeutics Diabetes Trial

FDA lifts a clinical hold against vTv Therapeutics cadisegliatin clinical program evaluating the first-in-class oral adjunctive therapy to insulin for...

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Human Drugs

Positive Hypoparathyroidism Trial Data: AstraZeneca

AstraZeneca reports positive data from the CALYPSO Phase 3 hypoparathyroidism trial, showing eneboparatide met its primary endpoint.

FDA General

Thousands of FDA Employees Return to Office

Thousands of FDA employees return to their offices 3/17 and deal with logistical issues, such as traffic, parking and finding work spaces.

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Medical Devices

FDA Warns on Hemodialysis Bloodline Shortage

FDA warns healthcare professionals about supply interruptions involving hemodialysis bloodlines.

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Federal Register

FDA Withdraws Sages NDA for Zulresso

Federal Register notice: FDA withdraws the approval of a Sage Therapeutics NDA for Zulresso (brexanolone) solution after it told the agency that the d...

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Human Drugs

FDA Withdraws 8 No-Longer-Marketed ANDAs

Federal Register notice: FDA withdraws approval of eight ANDAs from multiple applicants after they told the agency that the drugs were no longer marke...

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Federal Register

Garmendia Permanently Debarred Over Trial Fraud

Federal Register notice: FDA rejects a request for a hearing submitted by Bernardo Garmendia, and issues an order permanently debarring him from provi...

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Medical Devices

CareFusion Recalls BD Alaris Systems Manager

Becton Dickinsons CareFusion unit recalls its BD Alaris Systems Manager due to software issues that could provide incorrect therapy.

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Human Drugs

Korro Bio Gets Orphan Status for KRRO-110

FDA awards Korro Bio an orphan drug designation for KRRO-110 for treating Alpha-1 Antitrypsin Deficiency.

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Biologics

FDA Panel Determines Next Flu Vaccine Composition

FDA convenes a non-public interagency meeting to adopt recommendations for vaccine manufacturers and the virus strains to be used for the 2025-2026 U....