FDA Grants Approval to First Biosimilar for Treatment of Non-Hodgkin's Lymphoma
November 29th 2018Officials with the FDA have approved rituximab-abbs (Truxima, Celltrion) as a biosimilar to Rituxan (Genentech), making it the first biosimilar for the treatment of adult patients with non-Hodgkin’s lymphoma.
Read More
New Recall Announced for Products Containing Valsartan
November 28th 2018Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine/Valsartan combination tablets and Amlodipine Valsartan/Hydrochlorothiazide combination tablets, due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India.
Read More
FDA Grants Onc Drug Accelerated Approval for Key Genetic Driver of Cancer
November 27th 2018The FDA has granted an accelerated approval to larotrectinib (Vitrakvi, Loxo Oncology) for the treatment of adult and pediatric patients with solid tumors that have an NTRKgene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
Read More