Tag Archives: Approves

FDA Approves Triferic AVNU (ferric pyrophosphate citrate), Intravenous Formulation of Triferic for Replacement of Iron and Maintenance of Hemoglobin in Hemodialysis Patients

Print this page WIXOM, Mich., March 27, 2020 (GLOBE NEWSWIRE) — Rockwell Medical, Inc. (NASDAQ:RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming anemia management and improving outcomes for patients around the world, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its New Drug Application (“NDA”) for its intravenous formulation of Triferic, Triferic AVNU.… Read More »

FDA Approves Braftovi (encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy

Print this page April 8, 2020 – Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Braftovi® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior… Read More »

FDA Approves Sevenfact [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors

FDA Approves Sevenfact [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors Print this page LOUISVILLE, Ky., April 6, 2020 /PRNewswire/ — HEMA Biologics, LLC, (“HEMA Biologics”) today announced that the U.S. Food and Drug Administration (FDA) approved Sevenfact® [coagulation factor… Read More »

FDA Approves Ofev (Nintedanib), For The Treatment of Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype

FDA Approves Ofev (Nintedanib), For The Treatment of Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Print this page March 09, 2020 — The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the… Read More »

FDA Approves Sarclisa (isatuximab-irfc) for Patients with Relapsed Refractory Multiple Myeloma

FDA Approves Sarclisa (isatuximab-irfc) for Patients with Relapsed Refractory Multiple Myeloma Print this page BRIDGEWATER, N.J., March 2, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least… Read More »

FDA Approves Twirla (levonorgestrel and ethinyl estradiol) Contraceptive Patch

FDA Approves Twirla (levonorgestrel and ethinyl estradiol) Contraceptive Patch Print this page PRINCETON, N.J., Feb. 14, 2020 (GLOBE NEWSWIRE) — Agile Therapeutics, Inc., (Nasdaq: AGRX) (Agile or the Company), a forward-thinking women’s healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Twirla (levonorgestrel and ethinyl estradiol) transdermal system. INDICATION AND… Read More »