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FDA Grants Priority Review for Seattle Genetics’ Adcetris in Cutaneous T-Cell Lymphoma

BOTHELL, Wash.–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) based on data from the phase 3 ALCANZA trial and two phase 2 investigator-sponsored trials of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell …

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FDA Removes Clinical Hold on CEL-SCI’s Phase 3 Head and Neck Cancer Trial

VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (NYSE American: CVM) today announced it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the clinical hold that had been imposed on the Company’s Phase 3 cancer study with Multikine* (Leukocyte Interleukin, Inj.) has been removed and that all clinical trial activities …

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Exelixis Submits sNDA for Cabometyx for the Treatment of Previously Untreated Advanced Kidney Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced it has completed the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX®(cabozantinib) tablets as a treatment for patients with previously untreated advanced renal cell carcinoma (RCC). The sNDA submission is based on …

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FDA Grants Orphan Drug Designation to Ocugen’s OCU300 for Ocular Graft Versus Host Disease

MALVERN, Pa., Aug. 9, 2017 /PRNewswire/ — Ocugen, Inc., a clinical stage biopharmaceutical company developing novel treatments for sight-threatening diseases, today announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for OCU300 (brimonidine tartrate) for the treatment of ocular graft versus host disease (oGVHD). Ocular …

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FDA Grants Priority Review and Breakthrough Therapy Designation for Zelboraf in Erdheim-Chester Disease with BRAF V600 Mutation

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Zelboraf® (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation. ECD …

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AbbVie’s Mavyret Approved by FDA for Treatment of Hepatitis C in All Major Genotypes

NORTH CHICAGO, Ill., Aug. 3, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved MAVYRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVYRET is an 8-week, pan-genotypic treatment for …

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Jazz’s Vyxeos Receives FDA Approval for Treatment of Certain Poor Prognosis Acute Myeloid Leukemia

DUBLIN, Aug. 3, 2017 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has approved Vyxeos™ (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of Acute Myeloid Leukemia (AML), a rapidly progressing and life-threatening blood cancer.  …

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FDA Approves Imbruvica as First and Only Approved Therapy for Patients with Chronic Graft-Versus-Host-Disease

HORSHAM, Pa., Aug. 2, 2017 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.1 IMBRUVICA is the first and only FDA-approved medication for adult patients with …

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FDA Approves Vertex’s Kalydeco for 600+ Cystic Fibrosis Patients with One of Five Residual Mutations

BOSTON–(BUSINESS WIRE)– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved KALYDECO® (ivacaftor) for use in more than 600 people with cystic fibrosis (CF) ages 2 and older who have one of five residual function mutations that result in a splicing defect in the cystic fibrosis …

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FDA Expands Approval of Epculsa for the Treatment of Hepatitis C in Patients Co-Infected with HIV

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Epclusa® (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use …

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