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Oncopeptides Appealing Drug Withdrawal Request

[ Price : $8.95]

Oncopeptides says it is going to file a formal appeal of FDAs recent request for the company to voluntarily withdraw its accelerat...

Priority Review for Venatorx UTI Drug NDA

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FDA sets 2/22/2024 as the PDUFA action date for its priority review of Venatorx Pharmaceuticals NDA for cefepime-taniborbactam to ...

Breakthrough Status for AngioVac System

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FDA grants AngioDynamics a breakthrough device designation for its AngioVac System and its proposed indication for use to include ...

FDA Extends Review of Chikungunya Vaccine

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FDA extends by three months the review of a Valneva BLA for VLA1553, the companys chikungunya virus vaccine candidate.

Org. Structure for CDRH Strategic Group

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Federal Register notice: FDA announces a modification to the organizational structure of CDRHs Office of Strategic Patnerships and...

Panel to Discuss IVD Reclassifications

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Federal Register notice: FDA announces a 9/7-8 Medical Devices Advisory Committee Microbiology Devices Panel meeting that will dis...

Phillips Recalls Trilogy EVO Ventilators

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Philips Respironics recalls its Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators after detecting dust and dirt in the air...

FDA OKs Pfizer Multiple Myeloma Drug

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FDA gives Pfizer accelerated approval for Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen (BCMA)-directed CD3 ...

Biocon Malaysia Plant Hit with 8-item 483

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FDA issues Biocon an eight-item Form FDA-483 after an inspection last month at the firms Johor, Malaysia manufacturing facility ci...

Florida Amends FOIA Lawsuit Against FDA

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Florida amends a lawsuit against FDA charging the agency with violating the Freedom of Information Act by withholding records requ...