FDA News

Guardant Health Guardant360 CDx First FDA-Approved Liquid Biopsy for Comprehensive Tumor Mutation Profiling Across All Solid Cancers

REDWOOD CITY, Calif., Aug. 07, 2020 (GLOBE NEWSWIRE) — Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor). The Guardant360 CDx is also …

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FDA Approves Bayer’s Lampit for the Treatment of Children with Chagas Disease

WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer announced today that the United States Food and Drug Administration (FDA) has approved Lampit® (nifurtimox) for use in pediatric patients (from birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi (T. cruzi).1 Lampit, …

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FDA Grants Priority Review to Biogen and Eisai’s Investigational Alzheimer’s Disease Drug Aducanumab

CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The application has been granted Priority …

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FDA Expands Approval of ViiV’s Dovato, a Complete Two-Drug Regimen for Virologically Suppressed Adults with HIV-1

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine) as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral (ARV) regimen …

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FDA Approves GSK’s Blenrep for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

LONDON–(BUSINESS WIRE)–GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BLENREP (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory …

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FDA Expands Approval of Adaptive’s clonoSEQ Assay to Assess Minimal Residual Disease in Patients with Chronic Lymphocytic Leukemia

SEATTLE, Aug. 06, 2020 (GLOBE NEWSWIRE) — Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today received clearance from the U.S. Food and Drug Administration (FDA) for its clonoSEQ® Assay …

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FDA Grants Axsome Therapeutics’ AXS-12 Breakthrough Therapy Designation for Treatment of Narcolepsy

NEW YORK, Aug. 05, 2020 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for AXS-12 for the treatment of cataplexy …

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Roche Announces FDA Authorization for the first Epstein-Barr Virus Quantitative Test on the cobas 6800/8800 Systems to Improve Care for Transplant Patients

Basel, 5 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has authorized the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. This authorization gives healthcare professionals …

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FDA Grants Fast Track Designation to Leo Pharma’s Delgocitinib Cream for Treatment of Moderate-to-Severe Chronic Hand Eczema

BALLERUP, Denmark & MADISON, N.J.–(BUSINESS WIRE)–LEO Pharma A/S, a global leader in medical dermatology, today announced that delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of adults with moderate-to-severe chronic hand eczema …

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FDA Approves GW’s Epidiolex Oral Solution to Treat Seizures Associated with Tuberous Sclerosis Complex

CARLSBAD, Calif., Aug. 03, 2020 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with its U.S. subsidiary Greenwich Biosciences, Inc., today announced the U.S. Food and Drug Administration (FDA) has approved EPIDIOLEX® (cannabidiol) oral solution to treat …

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