Not Recommended For Approval Archives

FDA’s ODAC Votes Against Merck’s Keytruda For TNBC

Advisory Committees, Blockbusters, Checkpoint Inhibitors, Chemotherapy, Clinical Trials, Early-Stage Triple-Negative Breast Cancer (TNBC), FDA, FDA, High-Risk, Keytruda, Not Recommended For Approval, Oncologic Drugs Advisory Committee (ODAC), R&D, Therapeutics

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted against recommending Merck’s checkpoint inhibitor Keytruda (pembrolizumab) as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery.

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.

FDA panel votes against Lilly-Boehringer Ingelheim’s diabetes drug

Blood Sugar, FDA, FDA/Regulatory, Insulin, Not Recommended For Approval, SGLT2 Inhibitors, Type 1 Diabetes

Independent experts on an FDA advisory panel voted against the use of an already approved drug from Eli Lilly and Boehringer Ingelheim as an add-on to insulin therapy for type 1 diabetes.