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FDA Grants Breakthrough Device Designation to Caris Life Sciences’ MI Transcriptome Companion Diagnostic Test

IRVING, Texas, May 3, 2019 /PRNewswire/ — Caris Life Sciences®, a leading innovator in molecular science focused on precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company’s MI Transcriptome™ companion diagnostic (CDx) test. Designed to detect gene fusions in …

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Acacia Pharma Receives Complete Response Letter from the FDA for its Post-Operative Nausea & Vomiting Candidate Barhemsys

Cambridge, UK and Indianapolis, US – 3 May 2019: Acacia Pharma Group plc (“Acacia Pharma”), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that it has received a second Complete Response Letter from the US Food and Drug Administration (FDA) regarding its New Drug …

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FDA Approves Agios’ sNDA for Tibsovo as Monotherapy for Newly Diagnosed IDH1 Mutant AML Patients Not Eligible for Intensive Chemotherapy

CAMBRIDGE, Mass., May 02, 2019 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. Prescribing Information for …

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FDA Grants Breakthrough Device Designation to KidneyIntelX, AI-Enabled Diagnostic for Kidney Disease

NEW YORK, May 2, 2019 /PRNewswire/ — Renalytix AI plc (LON: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announced today that it has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), for its lead diagnostic, KidneyIntelX™. This is the first such …

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FDA Grants Limited Approval of Sanofi Pasteur’s Dengue Vaccine in Children

The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic …

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Heron Therapeutics Receives Complete Response Letter From the FDA for HTX-011 for the Management of Postoperative Pain

SAN DIEGO, May 1, 2019 /PRNewswire/ — Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that it received a Complete Response Letter (CRL) from the U.S. …

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FDA Approves AbbVie’s Mavyret as First Treatment for all Genotypes of Hepatitis C in Pediatric Patients

The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Mavyret was previously approved to treat HCV in adults in 2017. “Direct-acting antiviral drugs reduce the amount of HCV in the body …

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FDA Approves Kalydeco as First and Only CFTR Modulator to Treat Eligible Infants with Cystic Fibrosis as Early as 6 Months

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) for use in children with cystic fibrosis (CF) ages six months to less than 12 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to …

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Janssen Submits sNDA to the FDA for Expanded Approval of Erleada for Treatment of Metastatic Castration-Resistant Prostate Cancer

RARITAN, N.J., April 29, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for ERLEADA® (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). The …

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FDA Approves Samsung Bioepis’ Eticovo, a Biosimilar to Enbrel

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved ETICOVO™ (etanercept-ykro), a biosimilar referencing ENBREL® (etanercept), across all eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis. ETICOVO™ is Samsung Bioepis’ second …

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