Home / FDA News (page 5)

FDA News

Viela Bio’s Inebilizumab Receives Breakthrough Therapy Designation from the FDA for Treatment of Neuromyelitis Optica Spectrum Disorder

GAITHERSBURG, Md.–(BUSINESS WIRE)–Viela Bio today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the Company’s anti-CD19 monoclonal antibody inebilizumab, an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, life-threatening autoimmune disease affecting the central nervous system. “The Breakthrough …

Read More »

FDA Grants Breakthrough Therapy Designation to Genfit’s Elafibranor for Treatment of Primary Biliary Cholangitis

Lille (France), Cambridge (Massachusetts, United States), April 18, 2019 – GENFIT (Nasdaq and Euronext: GNFT – ISIN: FR0004163111), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that its lead product candidate elafibranor was granted Breakthrough …

Read More »

Agilent Receives an Expanded FDA Approval for its Companion Diagnostic in NSCLC

SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration has updated its approval of the company’s PD-L1 IHC 22C3 pharmDx assay. The assay can now be used as a companion diagnostic to identify a broader range of patients with stage III or metastatic …

Read More »

Ultragenyx’s UX007 Granted FDA Fast Track Designation and Rare Pediatric Disease Designation for Treatment of Long-Chain Fatty Acid Oxidation Disorders

NOVATO, Calif., April 16, 2019 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation and Rare Pediatric Disease designation …

Read More »

CRISPR Therapeutics and Vertex Announce FDA Fast Track Designation for CTX001 for the Treatment of Beta Thalassemia

ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, April 16, 2019 (GLOBE NEWSWIRE) — CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CTX001 for the treatment of transfusion-dependent beta thalassemia (TDT). CTX001 is …

Read More »

FDA Accepts and Grants Priority Review of Novartis’ Brolucizumab for Patients with Wet Age-Related Macular Degeneration

Basel, April 15, 2019 – Novartis announced that the US Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD. Seeking to make brolucizumab available as quickly as possible, Novartis used …

Read More »

FDA Grants Orphan Drug Designation to TG Therapeutics’ Umbralisib for the Treatment of Marginal Zone Lymphoma

NEW YORK, April 15, 2019 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to its phosphoinositide-3-kinase (PI3K) delta inhibitor, umbralisib (TGR-1202), for the treatment of patients with all three types of marginal zone lymphoma (MZL): nodal, extranodal, and splenic …

Read More »

FibroGen Receives Orphan Drug Designation from the FDA for Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy

SAN FRANCISCO, April 15, 2019 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN), a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients …

Read More »

FDA Approves Janssen’s Balversa for Treatment of Patients with Urothelial Carcinoma with Certain Genetic Alterations

HORSHAM, Pa., April 12, 2019  — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that BALVERSA™ (erdafitinib) received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor …

Read More »

FDA Clears HemoSonics’ Quantra QPlus System, a Rapid Coagulation Diagnostic for Hospital Transfusion Management

Charlottesville, VA – March 13, 2019 – HemoSonics today announced that its innovative Quantra Hemostasis Analyzer platform, and its initial QPlus cartridge have been granted de novo marketing authorization by the FDA and are now available for sale in the United States. The fast and easy-to-use Quantra QPlus System provides novel and …

Read More »