EU approves Sanofi, Regeneron’s Dupixent for adolescent eczema cases
The Dupixent product developed by Sanofi and the French company’s U.S. partner Regeneron won regulatory approval in Europe for moderate-to-severe cases of eczema in adolescents.
GSK’s HIV drug receives EU marketing nod
GlaxoSmithKline’s ViiV Healthcare received European Commission approval for Dovato to treat advanced-stage HIV infections in adults and adolescents above the age of 12 and weighing at least 40 kg.
Libtayo Approved in the European Union
The European Commission granted conditional marketing authorization for Libtayo (cemiplimab) for treating adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
European Commission Approves Talzenna for Patients with Inherited BRCA-Mutated Locally Advanced or Metastatic Breast Cancer
The European Commission approved Pfizer Inc.’s Talzenna (talazoparib), an oral polypolymerase inhibitor, as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene 1/2-mutations who have human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer.
AstraZeneca’s Lynparza gets EU nod as first-line ovarian cancer maintenance treatment
Lynparza was approved as a first-line maintenance treatment for a type of advanced ovarian cancer by the European Commission.
Novartis’ SMA Gene Therapy Treatment Approved by FDA, Priced at $2.125 Million
The U.S. Food and Drug Administration approved Zolgensma, a gene therapy that Novartis called a life-changing medicine, for children younger than 2 years of age who have been diagnosed with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 gene.
Novartis’ breast cancer treatment wins FDA approval
The FDA approved Novartis AG’s Piqray in combination with a hormone therapy for postmenopausal women, as well as for men, with a form of advanced breast cancer.
Celgene Receives European Commission Approvals for Revlimid and Imnovid-Based Triplet Combination Regimens for Multiple Myeloma
Celgene Corporation announced that the European Commission approved two new triplet regimens based on the company’s proprietary IMiD treatments, Revlimid (lenalidomide) and Imnovid (pomalidomide).
Waylivra Approved In EU For Treating FCS
Akcea Therapeutics Inc. and Ionis Pharmaceuticals Inc. announced that Waylivra received conditional marketing authorization from the European Commission as the only therapy for FCS.
FDA Advisory Panel Gives Mixed Review to Sanofi’s Dengue Vaccine
A mixed review from a U.S. FDA panel of experts could sink the chances of a green light for Sanofi’s dengue vaccine Dengvaxia.
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