Specialty Pharma Journal Specialty, Precision & Technology
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 Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the …
Tag Archives: Priority Review
December, 2018
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5 December
FDA Grants Priority Review to Novartis’ AVXS-101, a One-Time Treatment Designed to Address the Genetic Root Cause of SMA Type 1
Basel, December 3, 2018 – Novartis today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for AVXS-101, now known as ZOLGENSMA® (onasemnogene abeparvovec-xxxx)[1], an investigational gene replacement therapy for the treatment of spinal muscular atrophy (SMA) Type 1. ZOLGENSMA is designed to address the …
November, 2018
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21 November
FDA Grants Priority Review to Daiichi Sankyo’s Quizartinib for Treatment of Relapsed/Refractory FLT3-ITD Acute Myeloid Leukemia
TOKYO, MUNICH and BASKING RIDGE, N.J., Nov. 21, 2018 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute …
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14 November
FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Abraxane for PD-L1-Positive Metastatic TNBC
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of …
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12 November
FDA Grants Priority Review to Lynparza sNDA as Maintenance Therapy for Newly-Diagnosed, BRCAm Advanced Ovarian Cancer
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted priority review for the approval of LYNPARZA (olaparib) (two 150 mg …
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7 November
FDA Grants Priority Review for Dupixent as Potential Treatment for Adolescents with Uncontrolled Moderate-to-Severe Atopic Dermatitis
Paris and Tarrytown, NY – November 6, 2018 – The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or …
October, 2018
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26 October
FDA Grants Priority Review to Taiho Oncology’s sNDA for Lonsurf for Treatment of GEJ Adenocarcinoma
PRINCETON, N.J., October 25, 2018 – Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has accepted and granted priority review for the supplemental New Drug Application (sNDA) for LONSURF® (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including …
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25 October
FDA Grants Priority Review to Incyte’s Ruxolitinib for Treatment of Patients with Acute Graft-Versus-Host Disease
WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host-disease (GVHD) who have had an inadequate response to corticosteroids. The FDA grants Priority Review …
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17 October
FDA Grants Priority Review to AbbVie’s sNDA for Imbruvica in Combination with Gazyva for Previously Untreated Chronic Lymphocytic Leukemia
NORTH CHICAGO, Ill., Oct. 17, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) in previously untreated adult patients with chronic lymphocytic leukemia or …
August, 2018
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23 August
FDA Grants Priority Review to Bristol-Myers’ Empliciti in Patients with Relapsed or Refractory Multiple Myeloma
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior therapies, including …