Drugs

FDA Accepts 2 Merck sNDAs for HIV Drugs

FDA has accepted for review two Merck supplemental NDAs for Pifeltro (doravirine, 100 mg) and Delstrigo (doravirine 100 mg, lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg). The applications seek approval for Pifeltro (in combination with other antiretroviral medicines) and Delstrigo for use in people living with HIV-1 who are switching from a stable antiretroviral regimen and whose virus is suppressed. The agency has set a user fee review action target date of 9/20 for both submissions.

The submissions were based on data from the Phase 3 DRIVE-SHIFT trial that met its primary endpoint — demonstrating non-inferior efficacy of switching to Delstrigo compared with continuing on a baseline regimen of two nucleoside reverse transcriptase inhibitors plus a boosted protease inhibitor, or boosted elvitegravir, according to the company.

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