Medscape Medical News

Alert Europe Approves First Gene Therapy for Hemophilia B The European Commission has approved etranacogene dezaparvovec (Hemgenix), the first gene therapy for severe and moderately severe hemophilia B (congenital factor X1 deficiency).
News, February 21, 2023
Dapagliflozin Gets Expanded Heart Failure Indication in Europe The European Commission has expanded the indication of the SGLT2 inhibitor to include HF with mildly reduced and preserved ejection fraction, based on the DELIVER phase 3 trial.
News, February 08, 2023
Alert EMA Issues Positive Opinion on the Safety of Filgotinib The EMA has issued a positive opinion of the type II variation application of the JAK1 inhibitor filgotinib, based on testicular function safety data from two phase 2 clinical trials.
News, October 04, 2022
Alert Vutrisiran Receives EU Approval for hAATR Amyloidosis The RNAi therapeutic vutrisiran has been approved by the European Commission for hereditary transthyretin-mediated amyloidosis in adults with polyneuropathy on the basis of the phase 3 HELIOS-A trial.
News, September 20, 2022
Alert Generalized Myasthenia Gravis Drug Receives EU Approval Approved in the US last year, efgartigimod (Vyvgart) is a first-in-class targeted therapy for patients with generalized myasthenia gravis who test positive for the antiacetylcholine receptor antibody.
News, August 12, 2022
Alert Upadacitinib Gets European Nod for Nonradiographic AxSpA The European Commission approved oral upadacitinib for patients with an inadequate response to NSAIDs.
News, July 29, 2022
Alert Upadacitinib Recommended for Nonradiographic AxSpA in Europe The Janus kinase inhibitor is already approved for the treatment of active ankylosing spondylitis in the European Union.
News, June 28, 2022
Alert Baricitinib Backed for Approval for Alopecia Areata in the EU In February 2022, the FDA granted priority review for baricitinib in adults with severe alopecia areata.
News, May 20, 2022
Alert Topical Treatment for EB Recommended for Approval in the EU In February, the FDA declined to approve the company's new drug application as it was presented and asked the company to submit additional evidence of effectiveness for epidermolysis bullosa (EB).
News, April 27, 2022
Alert EU OK for New Drugs for Lung Cancer and Follicular Lymphoma Capmatinib for lung cancer and mosunetuzumab for follicular lymphoma have been recommended for approval in the European Union.
News, April 25, 2022
Alert CHMP Backs First Anti-CGRP in Europe for Migraine If approved, rimegepant would be the first CGRP receptor antagonist available in Europe and the only migraine medication approved for both acute and preventive treatment in adults.
News, March 02, 2022
Alert EMA Recommends PreHevbri Hepatitis B Vaccine for Approval The three-antigen hepatitis B vaccine received approval from the FDA in November 2021.
News, March 01, 2022
EU OKs Difelikefalin for CKD-Associated Pruritus, Generic Diabetes Meds CHMP adopts positive opinions for a new drug for pruritis associated with chronic kidney disease, two biosimilar insulins, and a generic form of the DPP-4 inhibitor sitagliptin for type 2 diabetes.
News, March 01, 2022
Alert EU Thumbs Up for Oral ADT for Prostate Cancer Relugolix (Orgovyx) offers an oral formulation of androgen deprivation therapy (ADT) for use in men with advanced hormone-sensitive prostate cancer.
News, February 28, 2022
Alert EMA Gives Green Light to New CAR-T Cell Therapy The European body has recommended approval of a new CAR-T cell therapy, as well as two generic version of dasatinib and a biosimilar of pegfilgrastim.
News, February 01, 2022
Alert EMA Panel Backs Linzagolix for Uterine Fibroid Symptoms Linzagolix is an oral gonadotropin-releasing hormone antagonist for the management of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
News, December 20, 2021
Alert Anifrolumab (Saphnelo) Gets Green Light for Approval in EU Anifrolumab, a monoclonal antibody against type I interferon receptor, was approved by the US Food and Drug Administration in July 2021.
News, December 18, 2021
Alert EMA Panel Endorses Two Cancer Drugs, One Sickle Cell Drug The recommendations from the European Medicines Agency panel mean the drugs will likely be approved soon.
News, December 17, 2021
Alert Diroximel Fumarate (Vumerity) Cleared for MS in Europe Diroximel fumarate is similar to dimethyl fumarate (Tecfidera) in efficacy but has a unique chemical structure that may induce less GI irritation.
News, November 17, 2021
Alert EU Green Light for Once-Weekly Growth Hormone for Kids A long-acting, once-weekly formulation of human growth hormone, lonapegsomatropin, nears approval in the EU for growth failure in kids aged 3 to 18 years.
News, November 16, 2021

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