FDA Approves First Non-Chemotherapy Combination Regimen

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA┬« (ibrutinib) in combination with rituximab for the treatment of Waldenstr├Âm’s macroglobulinemia (WM), a rare blood cancer.1 The approval expands the label for IMBRUVICA in WM beyond its current approved use as a monotherapy to include … More FDA Approves First Non-Chemotherapy Combination Regimen

FDA Takes Steps to Battle Opioid Abuse

The U.S. Food and Drug Administration today issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD). New draft guidance issued today outlines new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new … More FDA Takes Steps to Battle Opioid Abuse

Zika Test From Quest Diagnostics Authorized By FDA

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced that it has received a U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test). The test was developed by the reference laboratory business of Quest’s Focus Diagnostics, Inc., … More Zika Test From Quest Diagnostics Authorized By FDA