FDA News

FDA Approves Foundation Medicine’s FoundationOne Liquid CDx, a Comprehensive Pan-Tumor Liquid Biopsy Test

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne®Liquid CDx, the Company’s comprehensive pan-tumor liquid biopsy test. FoundationOne Liquid CDx will be commercially available on Friday, August 28 and is covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries in …

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FDA Grants Emergency Use Authorization to Abbott’s Fast, $5, 15-Minute Easy-to-Use COVID-19 Antigen Test

ABBOTT PARK, Ill., Aug. 26, 2020 /PRNewswire/ — Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit …

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Fluidigm Granted FDA Emergency Use Authorization for Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay for COVID-19

SOUTH SAN FRANCISCO, Calif., Aug. 25, 2020 (GLOBE NEWSWIRE) — Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Advanta™ Dx SARS-CoV-2 RT-PCR …

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AbbVie Submits Regulatory Application to FDA for Rinvoq for Treatment of Adults with Active Ankylosing Spondylitis

NORTH CHICAGO, Ill., Aug. 25, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for RINVOQ™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active …

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FDA Accepts Sarepta’s NDA for Casimersen for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45

CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) seeking accelerated approval for casimersen (SRP-4045) and provided a regulatory action date …

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FDA Grants Fast Track Designation to Metacrine’s MET409 for Treatment of NASH

SAN DIEGO, Aug. 25, 2020 (GLOBE NEWSWIRE) — Metacrine, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing differentiated therapies to treat patients with liver and gastrointestinal diseases, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation to MET409, the company’s lead farnesoid …

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FDA Rejects Tricida’s NDA for Veverimer for Treatment of Metabolic Acidosis and Slowing of Kidney Disease Progression in Patients with Metabolic Acidosis Associated with CKD

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that it received a Complete Response Letter (CRL) from …

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Turning Point Therapeutics Granted Fast Track Designation for Repotrectinib in NTRK-Positive TKI-Pretreated Advanced Solid Tumors

SAN DIEGO, Aug. 24, 2020 (GLOBE NEWSWIRE) — Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced the Food and Drug Administration (FDA) granted a third Fast-Track designation to its lead drug candidate, repotrectinib. The designation was granted …

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Exelixis Announces Submission of sNDA to the FDA Cabometyx in Combination with Opdivo for Advanced Renal Cell Carcinoma

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) for patients with advanced renal cell carcinoma (RCC). “We are excited to complete our first regulatory submission for CABOMETYX in combination …

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Guardant Health Receives FDA Emergency Use Authorization for its Guardant-19 Next Generation Sequencing-Based COVID-19 Test

REDWOOD CITY, Calif., Aug. 24, 2020 (GLOBE NEWSWIRE) — Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has granted the Guardant-19 test emergency use authorization (EUA) for use in the detection of the novel coronavirus, SARS-CoV-2. The test is being offered to Guardant Health employees …

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