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.
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.
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.
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.
Lynparza was approved as a first-line maintenance treatment for a type of advanced ovarian cancer by the European Commission.
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.
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 Corporation announced that the European Commission approved two new triplet regimens based on the company’s proprietary IMiD treatments, Revlimid (lenalidomide) and Imnovid (pomalidomide).
Akcea Therapeutics Inc. and Ionis Pharmaceuticals Inc. announced that Waylivra received conditional marketing authorization from the European Commission as the only therapy for FCS.
Roche received European Commission (EC) approval for the company’s Tecentriq drug in combination with Avastin and chemo as an initial treatment for people with a specific type of lung cancer.
