Oncology Approvals June-2018
Oncology Approval
FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. More Information. June 13, 2018Â More Information
FDA approved bevacizumab (Avastin, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. More Information. June 13, 2018 More Information
Generic Narcolepsy Drug Approved with Strict Safety Controls
The Food and Drug Administration (FDA) has approved Sodium Oxybate Oral Solution, the first generic version of Jazz’s Xyrem Oral Solution.
FDA Approves Generic Version of Sleep Disorder Drug Xyrem
The FDA has approved the first generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) oral solution to treat cataplexy and excessive daytime Continue Reading
New House E&C Chairman to Consider Value-Based Drug Price Negotiations
The newly minted chairman of the influential House Energy & Commerce Committee is looking to tackle Continue Reading