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FDA Rehires Fired Employees Due to Court Order

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FDA rehires over 1,000 probationary employees that were fired last month after a Maryland federal judge ordered HHS and other fede...

Incyte Plans NDA for JAK1 Inhibitor for Skin Condition

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Incyte says it will file an NDA for its JAK1 inhibitor povorcitinib and its use in adult patients with moderate to severe hidraden...

Ex-Magellan Execs Plead Guilty in Device Scandal

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Three former executives of Magellan Diagnostics plead guilty to federal charges after concealing a medical device malfunction invo...

Orca Bio T-Cell Leukemia Trial Meets Endpoint

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Orca Bio says its pivotal Phase 3 Precision-T study of Orca-T, an allogeneic T-cell immunotherapy, in certain leukemia patients me...

Hold Removed on vTv Therapeutics Diabetes Trial

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FDA lifts a clinical hold against vTv Therapeutics cadisegliatin clinical program evaluating the first-in-class oral adjunctive th...

Positive Hypoparathyroidism Trial Data: AstraZeneca

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

Thousands of FDA Employees Return to Office

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

FDA Warns on Hemodialysis Bloodline Shortage

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FDA warns healthcare professionals about supply interruptions involving hemodialysis bloodlines.

FDA Withdraws Sages NDA for Zulresso

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

FDA Withdraws 8 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws approval of eight ANDAs from multiple applicants after they told the agency that the drugs ...