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Human Drugs

Geron Myelodysplastic Syndromes NDA Approved

FDA approves a Geron NDA for Rytelo (imetelstat) for treating certain adult patients with low- to intermediate-1 risk myelodysplastic syndromes.

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Federal Register

CDER Proposes to Deny Vanda Hetlioz sNDA

Federal Register notice: CDER posts a proposal to refuse the approval of a supplemental NDA submitted by Vanda Pharmaceuticals for Hetlioz (tasimelteo...

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Federal Register

Panel to Review Imfinzi sBLA in Lung Cancer

Federal Register notice: FDA announces a 7/25 Oncologic Drugs Advisory Committee meeting to an AstraZeneca supplemental BLA for Imfinzi (durvalumab) i...

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FDA General

DePuy Synthes Gets 510(k) for Robotic Knee Device

FDA clears a DePuy Synthes 510(k) for the VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty.

Medical Devices

Genetic Signatures GI Parasite Detector Cleared

FDA clears a Genetic Signatures 510(k) for its EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated workflow.

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Human Drugs

Cipla Gets 1-item 483 After May Inspection

FDA leaves a one-item Form FDA-483 after an inspection last month at Cipla Ltd.s Maharasthra, India active pharmaceutical ingredient and finished dosa...

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Human Drugs

236 Potential Drug Shortages Prevented in 2023: FDA

FDA says there were 55 new drug shortages in CY 2023 and 236 potential shortages that were prevented through efforts by the agency, manufacturers, and...

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Biologics

Replimune Plans RP1 BLA After Positive Trial Data

Replimune plans a BLA submission for its RP1 therapy in combination with nivolumab for treating melanoma patients whove failed an anti-PD1 therapy.

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Federal Register

Agency Debars Sievert for 10 Years

Federal Register notice: FDA issues an order debarring Marina Sievert for 10 years from importing or offering for import any drug into the U.S.

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Human Drugs

FDA Accepts Medacs Treosulfan NDA Resubmission

Medexus Pharmaceuticals says FDA has accepted for review its Medac licensors resubmitted NDA for treosulfan, indicated for combination use with fludar...