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: sBLA
December, 2018
November, 2018
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5 November
Seattle Genetics Submits sBLA for Adcetris in Frontline Treatment of CD30-Expressing Peripheral T-Cell Lymphomas
BOTHELL, Wash.–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) announced today that it has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) based on data from the phase 3 ECHELON-2 trial evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing …
September, 2018
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13 September
FDA to Review Regeneron’s sBLA of Eylea Injection for the Treatment of Diabetic Retinopathy
TARRYTOWN, N.Y., Sept. 13, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA®(aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes. The target action …
August, 2018
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30 August
FDA Accepts Bristol-Myers’ sBLA for Sprycel in Pediatric Patients with Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia
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 Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The FDA action date is December …
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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 …
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17 August
FDA Approves Regeneron’s Eylea Injection sBLA in Wet Age-Related Macular Degeneration
TARRYTOWN, N.Y., Aug. 17, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year …
July, 2018
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11 July
FDA Grants Priority Review to Merck’s sBLA for Keytruda for Treatment of Advanced Hepatocellular Carcinoma
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a treatment for previously treated …
June, 2018
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22 June
FDA Accepts sNDA for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line NSCLC in Patients with Tumor Mutational Burden ≥10 mut/Mb
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). …
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13 June
FDA Grants Priority Review to Merck’s sBLA for Gardasil 9 for Prevention of HPV-Related Cancers and Diseases
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company’s 9-valent HPV vaccine. The application is seeking …
May, 2018
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7 May
FDA Grants Priority Review to Genentech’s Tecentriq for Initial Treatment of Metastatic Non-Squamous NSCLC
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 Avastin® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for …