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Moon Surgicals Maestro Surgical Device Cleared

[ Price : $8.95]

FDA clears a Moon Surgical 510(k) for its Maestro surgical system.

Geron Myelodysplastic Syndromes NDA Approved

[ Price : $8.95]

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

CDER Proposes to Deny Vanda Hetlioz sNDA

[ Price : $8.95]

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

Panel to Review Imfinzi sBLA in Lung Cancer

[ Price : $8.95]

Federal Register notice: FDA announces a 7/25 Oncologic Drugs Advisory Committee meeting to an AstraZeneca supplemental BLA for Im...

DePuy Synthes Gets 510(k) for Robotic Knee Device

[ Price : $8.95]

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

Genetic Signatures GI Parasite Detector Cleared

[ Price : $8.95]

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

Cipla Gets 1-item 483 After May Inspection

[ Price : $8.95]

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

236 Potential Drug Shortages Prevented in 2023: FDA

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

Replimune Plans RP1 BLA After Positive Trial Data

[ Price : $8.95]

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

Agency Debars Sievert for 10 Years

[ Price : $8.95]

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