Drugs

FDA Accepts AstraZeneca BLA for Bladder Cancer Therapy

FDA has accepted for priority review an AstraZeneca BLA for durvalumab, a PD-L1 human monoclonal antibody for treating patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has progressed during or after one standard platinum-based regimen. The agency has set a user fee review target for the second quarter of 2017.

Durvalumab is also being tested as monotherapy and in combination with tremelimumab (CTLA-4 mAb) in the Phase 3 DANUBE trial as first-line treatment for patients with metastatic UC, regardless of eligibility for cisplatin-based chemotherapy, AstraZeneca says. The combination is also being studied in Phase 3 trials in non-small cell lung cancer, head and neck squamous cell carcinoma and in Phase 2 and earlier trials in gastric cancer, pancreatic cancer, hepatocellular carcinoma and blood cancers, it adds.

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

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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