Chronic Lower Back Pain (cLBP) Archives

Nektar withdraws application for opioid painkiller after FDA panel’s vote

Addictions, Chronic Lower Back Pain (cLBP), FDA, FDA/Regulatory, Not Recommended For Approval, Opioids, Painkillers

Nektar Therapeutics withdrew the application for the company’s opioid painkiller for adults with chronic low back pain, after a U.S. Food and Drug Administration panel unanimously voted against the drug’s approval.

Nektar Forms New Subsidiary

Business, Chronic Lower Back Pain (cLBP), Company Launches, FDA, New Drug Applications, Opioids, Pain, PDUFA

With an opioid molecule awaiting regulatory review, Nektar Therapeutics announced the launch of Inheris Biopharma, which will be responsible for the commercialization of NKTR-181.

Pfizer and Lilly Receive FDA Fast Track Designation for Tanezumab

Chronic Lower Back Pain (cLBP), Chronic Pain, Monoclonal Antibodies, Osteoarthritis

Pfizer Inc. and Eli Lilly and Company announced that the U.S. Food and Drug Administration granted Fast Track designation for tanezumab for the treatment of chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP).