Drugs

Ensartinib NDA Accepted for Lung Cancer

FDA has accepted for review an Xcovery Holdings NDA for ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor for treating adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC). The submission is based on data from the Phase 3 eXalt3 study evaluating ensartinib vs crizotinib in the first-line treatment of ALK-positive NSCLC, according to the company. In the clinical trial, ensartinib “demonstrated robust and durable responses in ALK-positive NSCLC patients (both systemically and in the brain), with an extensively studied and well manageable safety profile,” Xcovery says. The agency has set a user fee review action target date of 12/28. Ensartinib is a next-generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome