FDA News

FDA Approves Pfizer’s Nivestym, a Biosimilar to Neupogen (filgrastim)

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product. “The FDA approval of NIVESTYM marks an important step in helping expand access to critical treatment options …

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FDA Approves Tibsovo, the First Targeted Treatment for Patients with Relapsed/Refractory AML with an IDH1 Mutation

Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that TIBSOVO® (ivosidenib) was granted approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate …

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SELLAS Receives Fast Track Designation from FDA for Galinpepimut-S for the Treatment of Multiple Myeloma

NEW YORK, July 20, 2018 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group Inc. (Nasdaq:SLS) (“SELLAS” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast …

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FDA Approves New Indications for Ferring’s Human Growth Hormone Zomacton

PARSIPPANY, N.J.–(BUSINESS WIRE)–Ferring Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ZOMACTON (somatropin) for injection in four additional pediatric indications: Idiopathic short stature (ISS) Short stature associated with Turner syndrome Short stature born small for gestational age (SGA) with no catch-up growth by 2 …

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FDA Approves Two New Indications for Novartis’ Breast Cancer Drug Through Novel Pilot Programs

Basel, July 18, 2018 – Novartis today announced a new approval for Kisqali® (ribociclib) from the US Food and Drug Administration (FDA) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali is now the only CDK4/6 inhibitor indicated for use with an aromatase inhibitor …

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CTI BioPharma Announces Pacritinib Program Update Following Type B Meeting with the FDA

SEATTLE, July 18, 2018 /PRNewswire/ — CTI BioPharma Corp. (NASDAQ:CTIC) today announced that it recently conducted a Type B meeting with the U.S. Food and Drug Administration (FDA) for its lead product candidate pacritinib. The purpose of the meeting was to discuss the regulatory pathway for pacritinib. Based on FDA feedback, the Company plans to conduct a randomized …

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FDA Grants Priority Review to Immunomedics’ Sacituzumab Govitecan for the Treatment of Metastatic Triple-Negative Breast Cancer

MORRIS PLAINS, N.J., July 18, 2018 (GLOBE NEWSWIRE) — Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Biologics License Application (BLA) for filing and granted Priority Review …

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FDA Grants Breakthrough Therapy Designation to Genentech’s Tecentriq in Combination with Avastin as First-Line Therapy for Advanced HCC

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 granted Breakthrough Therapy Designation for TECENTRIQ®(atezolizumab) in combination with Avastin® (bevacizumab) as an initial (first-line) treatment for people with advanced or metastatic hepatocellular carcinoma …

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FDA Approves Janssen’s Symtuza, the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV

TITUSVILLE, N.J., July 17, 2018 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SYMTUZA™, the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults. …

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FDA Grants Fast Track Designation to Tonix Pharmaceuticals’ Investigational Treatment for Agitation in Alzheimer’s Disease

NEW YORK, July 16, 2018 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational new drug, TNX-102 SL, for the treatment of agitation in Alzheimer’s disease. The same drug, TNX-102 SL, or …

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