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FDA Approves sNDA for Astellas’ Xospata, Adding Overall Survival Data for Patients with Acute Myeloid Leukemia with a FLT3 Mutation

TOKYO, May 30, 2019 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. product labeling for XOSPATA® (gilteritinib) to include final analysis data from …

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Zymeworks’ ZW25 Granted Fast Track Designation from the FDA for Treatment of Patients with Gastroesophageal Adenocarcinoma

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW25, a novel Azymetric™ bispecific antibody, for the first-line treatment of patients with HER2-overexpressing gastroesophageal adenocarcinoma in combination with standard of …

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Fibrocell Receives FDA Regenerative Medicine Advanced Therapy Designation for FCX-007 Gene Therapy for Treatment of RDEB

EXTON, Pa., May 29, 2019 (GLOBE NEWSWIRE) — Fibrocell Science, Inc. (Nasdaq: FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to FCX-007, …

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Arvinas Receives Fast Track Designation for its Targeted Protein Degrader ARV-110 for Treatment of Metastatic Castration-Resistant Prostate Cancer

NEW HAVEN, Conn., May 29, 2019 (GLOBE NEWSWIRE) — Arvinas, Inc. (Nasdaq: ARVN), a biopharmaceutical company creating a new class of therapies that degrades disease-causing proteins, today announced that its lead PROTAC® protein degrader, ARV-110, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for …

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FDA Grants Fast Track Designation to Imara’s IMR-687 for the Treatment of Sickle Cell Disease

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Imara, Inc., a clinical-stage biopharmaceutical company focused on sickle cell disease and other hemoglobinopathies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IMR-687, the company’s lead product candidate for the treatment of sickle cell disease. IMR-687 is currently being evaluated in a …

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Bayer Receives FDA Breakthrough Therapy Designation for Aliqopa for the Treatment of Marginal Zone Lymphoma

WHIPPANY, N.J., May 29, 2019 /PRNewswire/ — Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Aliqopa™ (copanlisib) for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least two prior therapies. MZL is an indolent form …

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FDA Approves Revlimid in Combination with Rituximab for Patients with Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) approved REVLIMID® (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. This is the first FDA-approved …

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FDA Grants Orphan Drug Designation to Applied Therapeutics AT-007 for Treatment of Galactosemia

NEW YORK, May 28, 2019 (GLOBE NEWSWIRE) — Applied Therapeutics Inc. (Nasdaq:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to …

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FDA Approves Novartis’ Piqray, the First and Only Treatment for Patients with a PIK3CA Mutation in HR+/HER2- Advanced Breast Cancer

Basel, May 24, 2019 – Novartis today announced the US Food and Drug Administration (FDA) has approved Piqray® (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an …

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FDA Approves Incyte’s Jakafi for the 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 approved Jakafi® (ruxolitinib) for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. Jakafi is the first and only FDA-approved treatment for this indication. “For the first time, patients …

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