Johnson & Johnson’s Spravato, a nasal spray for depression and potential blockbuster medicine, won recommendation for approval from a European Medicines Agency panel.
The world’s first Ebola vaccine was recommended for approval by European drug regulators in a move hailed by the World Health Organization (WHO) as a “triumph for public health.”
Roche’s Tecentriq won European approval for use against a tough-to-treat breast cancer, helping the Swiss drugmaker to widen use of an immunotherapy that has so far been eclipsed in revenue terms by more-established rival medicines.
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.
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.
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.