FDA News

FDA Approves Crysvita as the First Therapy for Treatment of Tumor-Induced Osteomalacia

NOVATO, Calif. and TOKYO, June 18, 2020 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultra-rare diseases, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions using the latest biotechnology, today …

Read More »

FDA Grants Rare Pediatric Disease Designation to Dicerna’s Nedosiran for Treatment of Primary Hyperoxaluria

LEXINGTON, Mass.–(BUSINESS WIRE)–Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced that the U.S. Food and Drug Administration (“FDA” or the “agency”) has granted rare pediatric disease designation for nedosiran, an investigational RNAi therapy being developed as a once-monthly …

Read More »

FDA Grants Accelerated Approval to Merck’s Keytruda for Patients with Tumor Mutational Burden-High Solid Tumors

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 approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase …

Read More »

FDA Approves FoundationOne®CDx as the First Companion Diagnostic to Identify Patients with Solid Tumors that are Tumor Mutational Burden-High and Appropriate for Treatment with Keytruda

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne®CDx as a companion diagnostic for KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, which was also approved under accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 …

Read More »

Ipsen Receives Fast Track Designation from the FDA for its Liposomal Irinotecan as a First-Line Combination Treatment for Metastatic Pancreatic Cancer

Ipsen (Euronext: IPN; ADR: IPSEY) today announced the United States Food and Drug Administration (FDA) has granted the company Fast Track designation for the investigational use of liposomal irinotecan (ONIVYDE®) in combination with 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) together, known as NALIRIFOX for patients with previously untreated, unresectable, locally …

Read More »

FDA Approves Novartis’ Cosentyx for Treatment of Active Non-Radiographic Axial Spondyloarthritis

Basel, June 17, 2020 — Novartis, a leader in rheumatology and immuno-dermatology, today announced that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming Cosentyx efficacy in addressing the axial spondyloarthritis (axSpA) disease spectrum9. “The results from the PREVENT trial …

Read More »

FDA Grants Accelerated Approval to Jazz’s Zepzelca for the Treatment of Metastatic Small Cell Lung Cancer

DUBLIN, June 15, 2020 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced along with its partner PharmaMar (MSE: PHM) that the U.S. Food and Drug Administration (FDA) approved Zepzelca™ (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.1 Zepzelca was approved under accelerated approval based on overall response …

Read More »

FDA Approves Lyumjev, Lilly’s New Rapid-Acting Insulin

INDIANAPOLIS, June 15, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Lyumjev™ (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company’s (NYSE: LLY) new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. Lyumjev is a novel formulation of insulin lispro, developed to speed …

Read More »

FDA Grants Breakthrough Device Designation to Thermo Fisher’s Oncomine Precision Assay to Identify IDH1 and IDH2 Mutations in Low-Grade Glioma Patients

CARLSBAD, Calif., June 15, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Thermo Fisher Scientific’s Oncomine Precision Assay to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881). The …

Read More »

FDA Approves Merck’s GARDASIL 9 for the Prevention of Certain HPV-Related Head and Neck Cancers

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 approved an expanded indication for GARDASIL 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, …

Read More »