Drugs

FDA Complete Response on Verrica NDA

FDA has issued Verrica Pharmaceuticals a complete response letter regarding its NDA for VP-102 for treating molluscum contagiosum. Previously, the agency extended by three months (until 9/23) to allow additional time to review information submitted by the company in response to comments about its human factors study.

The letter identified deficiencies at a contract manufacturer’s facility, “which are not specifically related to the manufacturing of VP-102 but instead raise general quality issues at the facility,” Verrica says. “More importantly, the FDA did not identify any clinical, safety or product specific chemistry, manufacturing, and controls deficiencies related to VP-102.”

Molluscum is a contagious viral skin disease that affects about six million people in the U.S. VP-102 is described by the company as a proprietary drug-device combination containing cantharidin that is delivered via a single-use applicator that allows for precise topical dosing and targeted administration.

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