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).
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.
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.
Clovis Oncology Inc. announced that the European Commission approved the use of Rubraca (rucaparib) for a second indication: as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Amgen announced that the European Commission approved an expanded indication for Blincyto monotherapy to include adult patients with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1 percent.
Pfizer Inc. announced that the European Commission approved Xeljanz (tofacitinib citrate) 10 mg twice daily for at least eight weeks, followed by Xeljanz 5 mg BID or 10 mg BID, for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
The European Commission approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
The European Commission approved Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive CML in chronic phase.