FDA Approvals, News & Updates

The US Food and Drug Administration (FDA) approved regorafenib (Stivarga, Bayer HealthCare Pharmaceuticals, Inc.) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemo­therapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. Regorafenib approval was granted on September 27, 2012.
The US Food and Drug Administration (FDA) has approved omacetaxine mepesuccinate subcutaneous injection (Synribo, Teva Pharmaceutical Industries) for the treatment of adult patients with chronic myeloid leukemia (CML) with resistance and/or intolerance to 2 or more tyrosine kinase inhibitors (TKIs).
The US Food and Drug Administration (FDA) approved regorafenib (Stivarga, Bayer HealthCare Pharmaceuticals, Inc.) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemo­therapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. Regorafenib approval was granted on September 27, 2012.
On October 4, 2012, the FDA and the US Centers for Disease Control and Prevention (CDC) recommended that all healthcare professionals cease use and remove from pharmaceutical inventory any product produced by the New England Com­pounding Center (NECC).

The US Food and Drug Administration (FDA) approved bosutinib tablets (Bosulif; Pfizer) for the treatment of adults with chronic, accelerated, or blast phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML) who did not respond or were resistant to prior therapy.

The FDA granted expedited approval for enzalutamide (Xtandi; Medivation and Astellas Pharma US) on August 31, 2012. Enzalutamide was approved for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel.

On July 20, 2012, the FDA granted accelerated approval to carfilzomib injection (Kyprolis; Onyx Pharmaceuticals) for the treatment of patients with multiple myeloma who have received at least 2 prior therapies, including bortez­omib and an immunomodulatory agent, and who have demonstrated disease progression on or within 60 days of the completion of their last therapy.

The US Food and Drug Administration (FDA) approved bosutinib tablets (Bosulif; Pfizer) for the treatment of adults with chronic, accelerated, or blast phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML) who did not respond or were resistant to prior therapy.

The FDA granted expedited approval for enzalutamide (Xtandi; Medivation and Astellas Pharma US) on August 31, 2012. Enzalutamide was approved for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel.

On July 20, 2012, the FDA granted accelerated approval to carfilzomib injection (Kyprolis; Onyx Pharmaceuticals) for the treatment of patients with multiple myeloma who have received at least 2 prior therapies, including bortez­omib and an immunomodulatory agent, and who have demonstrated disease progression on or within 60 days of the completion of their last therapy.

Page 11 of 14
Results 101 - 110 of 137