Drugs

FDA Not Meeting PDUFA Dates on 2 Pfizer NDAs

FDA has notified Pfizer that it will not meet the already-extended PDUFA goal dates for the company’s NDA for abrocitinib to treat adults and adolescents with moderate to severe atopic dermatitis and the sNDA for Xeljanz/Xeljanz XR (tofacitinib) for treating adults with active ankylosing spondylitis. The agency cited its ongoing review of Pfizer’s ORAL Surveillance postmarketing safety study of Xeljanz in rheumatoid arthritis patients as a factor in the delay, Pfizer said.

In April, the agency said that safety concerns with JAK inhibitors were causing review extensions for Lilly/Incyte and Pfizer submissions. The concerns arose from the FDA-required Xeljanz postmarketing safety study. FDA has warned that interim trial results showed an increased risk of blood clots and death with the 10 mg twice-daily dosage.

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