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    REGULATORY AFFAIRS


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    REGULATORY AFFAIRS from The Pharmaceutical Marketing Group is a regular email newsletter about regulatory affairs.

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    Clovis Oncology’s Rubraca® (rucaparib) Granted FDA Priority Review for Advanced Prostate Cancer

    BOULDER, Colo.--(BUSINESS WIRE)--Clovis Oncology, Inc. (NASDAQ: CLVS) announced today...

    TransEnterix Announces Submission of 510(k) to FDA for First Machine Vision System in Robotic Surgery

    RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--TransEnterix, Inc. (NYSE American: TRXC),...

    Imago Receives Fast Track Designation from U.S. FDA for Bomedemstat for Treatment of Essential Thrombocythemia

    SAN FRANCISCO--(BUSINESS WIRE)--Imago BioSciences, Inc., a clinical-stage biotechnology company...

    Meissa Vaccines Receives U.S. FDA Fast Track Designation for Respiratory Syncytial Virus Vaccine, MV-012-968

    SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Meissa Vaccines (“Meissa”), a biotechnology...

    FDA Grants Breakthrough Device Designation to Reflow Medical’s Temporary Spur Stent System

    SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Reflow Medical announces that the Temporary...

    Penumbra Announces FDA Clearance of Indigo® Aspiration System for Treatment of Pulmonary Embolism

    ALAMEDA, Calif.--(BUSINESS WIRE)--Penumbra, Inc. (NYSE: PEN), a global healthcare...

    Newron Announces Initiation of New Clinical Trial With Evenamide in Patients With Schizophrenia, Following Approval of Plan By FDA

    MILAN & MORRISTOWN, N.J.--(BUSINESS WIRE)--Newron Pharmaceuticals S.p.A. (“Newron”) (SIX:...