FDA approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage cervical cancer. The new indication is approved for use in combination with paclitaxel and cisplatin or in combination with paclitaxel and topotecan.
FDA approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.
FDA granted Breakthrough Therapy designation to investigational bispecific T cell engager antibody blinatumomab, for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia.
The European Commission issued marketing authorization approval for Halaven (eribulin) for locally advanced or metastatic breast cancer that has progressed after at least one chemotherapeutic regimen for advanced disease.
FDA granted Breakthrough Therapy status to CTL019, an investigational chimeric antigen receptor therapy for the treatment of pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia.
Mylan Inc. launched Carboplatin Injection, 50 mg/5 ml, in multi-dose vials—the generic version of Bristol-Myers Squibb's Paraplatin Injection.
FDA granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of metastatic non-small cell lung cancer.
FDA granted orphan drug designation to ADXS-HPV for the treatment of stage II-IV invasive cervical cancer. ADXS-HPV is an immunotherapy drug candidate, developed by Advaxis Inc., which is designed to target cells expressing the HPV gene E7. Expression of the E7 gene from high-risk HPV variants is responsible for the transformation of infected cells into... […]
FDA approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma.
The European Commission approved a subcutaneous formulation of MabThera (rituximab) for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma.
