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FDA Approves Shire’s Takhzyro, a First-of-its-Kind mAb Preventive Treatment for Hereditary Angioedema

Dublin, Ireland – August 23, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, today announced that following priority review, the U.S. Food and Drug Administration (FDA) has approved TAKHZYRO™ (lanadelumab-flyo) injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 …

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FDA Approves Diacomit for Treatment of Seizures Associated with Dravet Syndrome

GENTILLY, France, Aug. 23, 2018 /PRNewswire/ — BIOCODEX SAS is pleased to announce that on August 20th, 2018, the Food and Drug Administration (FDA) has approved DIACOMIT (stiripentol) for the treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking clobazam. DIACOMIT is …

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FDA Grants Priority Review to Bristol-Myers’ Empliciti in Patients with Relapsed or Refractory Multiple Myeloma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior therapies, including …

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FDA Grants Rare Pediatric Disease Designation to Krystal’s KB105 for Patients with TGM-1-Deficient Autosomal Recessive Congenital Ichthyosis

PITTSBURGH, Aug. 23, 2018 (GLOBE NEWSWIRE) — Krystal Biotech, Inc. (Nasdaq: KRYS), a gene therapy company dedicated to developing and commercializing novel treatments for patients suffering from dermatological diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation (“RPDD”) to the company’s gene …

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FDA Approves Roche’s Cobas EGFR Mutation Test v2 as a Companion Diagnostic with Iressa

PLEASANTON, Calif., Aug. 23, 2018 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced approval from the U.S. Food and Drug Administration (FDA) for the cobas® EGFR Mutation Test v2 as a companion diagnostic test (CDx) with IRESSA®. A CDx test provides information that is essential for the safe …

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FDA Approves Dompé’s Oxervate for Treatment of Neurotrophic Keratitis, a Rare Eye Disease

MILAN and SAN BRUNO, Calif., Aug. 22, 2018 /PRNewswire/ — Dompé today announced that the U.S. Food and Drug Administration (FDA) has approved OxervateTM (cenegermin-bkbj ophthalmic solution), a breakthrough therapy for neurotrophic keratitis (NK), a rare and progressive eye disease that can lead to corneal scarring and vision loss.1 “Neurotrophic …

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FDA Expands Approval of Agilent’s Companion Diagnostic in Urothelial Carcinoma

SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use in urothelial carcinoma. The assay is now approved to identify patients with urothelial carcinoma who may benefit from KEYTRUDA, an anti-PD-1 …

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FDA Approves Expanded Label for Merck’s Keytruda in Patients with Metastatic Nonsquamous NSCLC

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 label for KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA®) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous …

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FDA Grants Fast Track Designation to Aravive Biologics’ AVB-S6-500 for Treatment of Ovarian Cancer

HOUSTON–(BUSINESS WIRE)–Aravive Biologics, Inc. announced today that the U.S. Food and Drug Administration has granted Fast Track Designation to AVB-S6-500 as a potential treatment for platinum-resistant recurrent ovarian cancer. “Gaining Fast Track Designation is an important recognition of the potential that AVB-S6-500 has to offer to meet a critical unmet …

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FDA Accepts Priority Review of Alexion’s ALXN1210 as a Treatment for Paroxysmal Nocturnal Hemoglobinuria

BOSTON–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s Biologics License Application (BLA) for approval of ALXN1210, the Company’s investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). The FDA set a …

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