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Breakthrough Status for AngioVac System

[ Price : $8.95]

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

Knoll Debarred by FDA for 5 Years

[ Price : $8.95]

Federal Register notice: FDA debars Ildiko M. Knoll for five years from importing or offering for import any drug into the U.S.

FDA Extends Review of Chikungunya Vaccine

[ Price : $8.95]

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

[ Price : $8.95]

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

Panel to Discuss IVD Reclassifications

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Clinical Hold on AML Cell Therapy

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FDA places a clinical hold on a 2seventy bio Phase 1 study (PLAT-08) of SC-DARIC33 in acute myeloid leukemia after a patient death...