FDA News

FDA Grants CSL Behring’s Hizentra Orphan Drug Exclusivity for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy

KING OF PRUSSIA, Pa., Dec. 9, 2019 /PRNewswire/ — Global biotherapeutics leader CSL Behring announced today that Hizentra received orphan-drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability …

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Galderma’s Nemolizumab Receives Breakthrough Therapy Designation from the FDA for the Treatment of Prurigo Nodularis

LAUSANNE, Switzerland–(BUSINESS WIRE)–Galderma today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational therapy nemolizumab for the treatment of pruritus associated with prurigo nodularis. Prurigo nodularis is a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas …

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FDA Grants Breakthrough Therapy Designation to Janssen’s BCMA CAR-T Therapy for the Treatment of Relapsed or Refractory Multiple Myeloma

RARITAN, N.J., Dec. 6, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-68284528 (JNJ-4528), an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in previously treated patients with multiple myeloma. Breakthrough …

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FDA Approves Amgen’s Avsola (infliximab-axxq), for the Same Indications as Remicade

THOUSAND OAKS, Calif., Dec. 6, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AVSOLA™ (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn’s Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis (UC) in …

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ViiV Submits Fostemsavir NDA to the FDA for Treatment of HIV in Adults with Few Treatment Options Available

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today completed submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of …

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ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, a privately held immunotherapy company, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its interleukin-15 (IL-15) agonist complex, N-803, in combination with Bacillus Calmette-Guerin (BCG), for the treatment of patients with BCG-unresponsive non-muscle invasive bladder carcinoma in situ (CIS). This grant …

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FDA Grants Breakthrough Therapy Designation to Bristol-Myers Squibb’s Orencia to Help Prevent Acute Graft-Versus-Host Disease

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA® (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors. There are no approved therapies for the prevention of …

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FDA Approves Genentech’s Tecentriq Plus Chemotherapy for Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

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) approved Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane® [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults with metastatic non-squamous non-small cell lung cancer …

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FDA Grants Regenerative Advanced Therapy Designation to Adaptimmune’s Investigational Synovial Sarcoma Treatment

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Dec. 03, 2019 (GLOBE NEWSWIRE) — Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announced that it has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for ADP-A2M4 for the treatment of synovial sarcoma. …

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Immunomedics Resubmits its BLA to the FDA for Accelerated Approval of Sacituzumab Govitecan for Treatment of Metastatic Triple-Negative Breast Cancer

MORRIS PLAINS, N.J., Dec. 03, 2019 (GLOBE NEWSWIRE) — Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of sacituzumab govitecan for …

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