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FDA Extends Action Date for Xeljanz sNDA in Ulcerative Colitis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib), an oral treatment under investigation for adult patients with moderately to severely active ulcerative colitis (UC). The …

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FDA Approves GSK’s Nucala for the Treatment of Eosinophilic Granulomatosis with Polyangiitis

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome.  GSK submitted a supplemental Biologics License Application (sBLA) for mepolizumab, an interleukin-5 (IL-5) antagonist, in June …

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FDA Approves Sanofi’s Admelog, a Biosimilar of Humalog

PARIS, Dec. 11, 2017 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Admelog®, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. “Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes. Complementing our existing insulin …

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FDA Expands Orphan Drug Designation for Alnylam’s Patisiran to Treatment of Transthyretin-Mediated Amyloidosis

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today the U.S. Food and Drug Administration (FDA) has granted a request to amend the orphan drug designation for patisiran to the treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis). This is an expansion to patisiran’s prior designation which was for …

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FDA Grants Priority Review to Merck’s sBLA for Keytruda in Primary Mediastinal Large B-Cell Lymphoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from the phase 2 KEYNOTE-170 trial investigating the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in the cohort of patients with relapsed or refractory primary mediastinal large B-cell lymphoma (PMBCL), a type of …

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MeiraGTx’s Leber’s Congenital Amaurosis Drug Receives Rare Pediatric Disease Designation from the FDA

LONDON and NEW YORK, Dec. 7, 2017 /PRNewswire/ — MeiraGTx, a London and New York-based gene therapy company, today announced that the Offices of Orphan Products Development and Pediatric Therapeutics of the U.S. Food and Drug Administration (FDA) have granted rare pediatric disease designation to the Company’s gene therapy product …

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Sunovion’s Lonhala Magnair Inhalation Solution Approved by the FDA for Treatment of COPD

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution (25 mcg twice daily), also known as SUN-101/eFlow®, for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), …

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FDA Grants Full Approval for Genentech’s Avastin for the Treatment of Glioblastoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin®(bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease). Avastin …

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Clovis Oncology’s Ovarian Cancer Drug Granted Priority Review from the FDA

BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In October, …

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Lilly’s Taltz Receives FDA Approval for the Treatment of Active Psoriatic Arthritis

INDIANAPOLIS, Dec. 1, 2017 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis (PsA).1 Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for …

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