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    NEWS

    DRUGS & DEVELOPMENTS

    MARKET INTEL by PharmaCompass

    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Huonslab Strengthens HyDIFFUZE™ IP with US & EU Request

    BUSINESSWIRE

    Argenx Publishes Adhere Study Data In The Lancet Neurology

    GLOBENEWSWIRE

    Genentech`s Biologic Zunovo (Hyaluronidase) Receives in US

    FDA

    Amphastar`s Biologic Amphadase (Hyaluronidase) Receives Suppl Approvals in US

    FDA

    Amivantamab Biologics License Application Submitted For EGFR-NSCLC

    PR NEWSWIRE

    FDA Accepts BMS Subcutaneous Nivolumab Application

    BUSINESSWIRE

    J&J submits sBLA to U.S. FDA seeking approval of DARZALEX FASPRO

    PR NEWSWIRE

    Subcutaneous Nivolumab Shows Noninferiority Compared to Intravenous Opdivo in ccRCC

    BUSINESSWIRE

    Halozyme Announces Takeda Receives FDA Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

    PRESS RELEASE

    DARZALEX shows significant improvement in multiple myeloma

    PR NEWSWIRE

    Alteogen`s Tergase Shows Excellent Immunogenicity Profile

    PR NEWSWIRE

    Bioindustria Laboratorio Italiano Medicinali S.p.A. Fails EDQM Inspection

    EDQM

    Janssen Biotech`s Biologic Darzalex Faspro (Daratumumab; Hyaluronidase) Receives Approval in the U.S.

    FDA

    FDA Grants Approval to Janssen`s DARZALEX FASPRO + Carfilzomib & Dexamethasone

    PRNEWSWIRE

    Janssen`s Biologic Darzalex Faspro gets Approval in the U.S.

    FDA

    Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO

    PRNEWSWIRE

    Genentech`s Biological Rituximab; Hyaluronidase Receives Approval In US

    FDA

    Janssen seeksFDA approval for Darzalex Faspro to treat patients with amyloidosis

    PHARMABIZ

    J&J files U.S. application for expanded use of Darzalex Faspro

    SEEKINGALPHA

    Genentech`s Rituxan Hycela (rituximab;Hyaluronidase) Receives Approval In U.S

    FDA

    Janssen Biotech`s Darzalex Faspro(Daratumumab;Hyaluronidase) Approval in US

    FDA

    Genentech`s RITUXAN HYCELA (Rituximab; Hyaluronidase) Receives Supplemental Approval in US

    FDA

    Alteogen Enters into a Non-exclusive License Agreement a Global Pharma Company

    BUSINESS WIRE

    FDA Compiles List of NDAs Transitioning to BLAs Next March

    RAPS

    Enforcement Report - Week of August 15, 2018

    FDA

    RITUXAN HYCELA approved FDA for subcutaneous injection in certain blood cancers

    BIOSPECTRUM

    Genentech’s Hyaluronidase;Rituximab Receives Supplemental Approval In US

    FDA

    Shire launches immunodeficiency drug for children

    PHARMATIMES

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