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V2ACT Therapeutics(TM), LLC Announces FDA Clearance of an IND Application to proceed with a Phase 1/2a Study of V2ACT for the Treatment of Pancreatic Cancer

– V2ACT Therapeutics(TM), LLC is a joint venture of Genelux Corporation and TVAX Biomedical, Inc.- V2ACT is a proprietary immuno-oncology modality composed of Olvi-Vec (oncolytic immunotherapy) and V-ACT (vaccine-enhanced adoptive cell therapy).- V2ACT… […]

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Helix Receives Expanded Emergency Use Authorization for On-site Unsupervised Self-Collection and Asymptomatic Screening with the Helix® COVID-19 Test

As one of the few tests with these indications, the Helix® COVID-19 Test provides organizations with significantly more flexibility in how they operate testing sites to support broad back-to-work and school screening

SAN MATEO, Calif., Oct. 26, 2020… […]

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Halozyme Announces Janssen Submission For FDA Approval Of DARZALEX FASPRO(TM) (daratumumab and hyaluronidase-fihj) For The Treatment Of Patients With Light Chain (AL) Amyloidosis

– Follows FDA Approval of DARZALEX FASPRO(TM) Utilizing ENHANZE® Technology in May 2020 for the Treatment of Patients with Multiple Myeloma –

SAN DIEGO, Sept. 10, 2020 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that it… […]

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FDA Approves First NGS-Based Companion Diagnostic for RET Fusion-Positive Non-Small Cell Lung Cancer

CDx approval expands clinical utility of Oncomine Dx Target Test to identify candidates for GAVRETO

CARLSBAD, Calif., Sept. 8, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific… […]

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FDA Issues Emergency Use Authorization for ChromaCode’s High-Throughput HDPCR(TM) SARS-CoV-2 Real-Time PCR Assay

High-Definition PCR SARS-CoV-2 assay increases test throughput and reduces complexity of interpretation; ChromaCode customers enjoy inventory guarantee

CARLSBAD, Calif., June 10, 2020 /PRNewswire/ — ChromaCode, Inc., a company redefining molecular … […]

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Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States

SAN DIEGO, May 19, 2020 /PRNewswire/ — Invivoscribe to offer the LeukoStrat® CDx FLT3 Mutation Assay as an FDA approved kit with analysis software.

In 2017, Invivoscribe’s LeukoStrat® CDx FLT3 Mutation Assay became the first FDA approved FLT3… […]

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Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO(TM) Utilizing Halozyme’s ENHANZE® Technology For The Treatment Of Patients With Multiple Myeloma

– Janssen’s DARZALEX FASPRO(TM) is a subcutaneous co-formulation of DARZALEX? and Halozyme’s ENHANZE? technology — Innovative, fixed-dose formulation demonstrates consistent efficacy to intravenous DARZALEX? with lower rate of infusion-related reactio… […]