FDA Panel Backs ReCor’s Renal Denervation System for Hypertension
The Paradise ultrasound renal denervation system got backing from the FDA’s Circulatory System Devices Panel as a possible treatment for hypertension, as manufacturer ReCor continues to hope for regulatory approval. On Tuesday, FDA advisors voted 10-2 that the benefits of the Paradise catheter-based system outweigh its risks when used to reduce blood pressure (BP) in […]
Ocaliva for NASH Gets Thumbs Down From FDA Advisors
A panel of FDA’s outside experts said obeticholic acid (Ocaliva) does not have a favorable risk-benefit profile for treating nonalcoholic steatohepatitis (NASH) with pre-cirrhotic liver fibrosis, and recommended against accelerated approval of the drug. On Friday, the Gastrointestinal Drugs Advisory Committee voted 12-2 (with two abstentions) that the improvements in liver scarring seen in the […]
Federal Judge Halts FDA’s Abortion Pill Approval
A federal judge in Texas on Friday suspended the FDA’s 2000 approval of mifepristone (Mifeprex) — the most commonly used drug for medication abortion nationwide. Importantly, Judge Matthew Kacsmaryk, of the U.S. District Court for the Northern District of Texas, also stayed the effective date of his order for 7 days to allow the federal […]
House Republican Argues Against FDA Budget Increase
During a House hearing on the FDA’s 2024 budget request, a Republican subcommittee chair said he was not too pleased with the idea of a $7.2 billion budget — an 8% increase over the 2023 enacted agency budget. The $522 million increase includes $372 million in new budget authorities coupled with $150 million for new […]
Second RSV Vaccine for Older Adults Gets Thumbs Up From FDA Advisors
A panel of FDA’s outside advisors recommended the agency approve GSK’s respiratory syncytial virus (RSV) vaccine for older adults, a day after backing Pfizer’s RSV vaccine candidate for that same population. By votes of 12-0 on efficacy and 10-2 on safety, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said the available data support […]
FDA Flags Potential Guillain-Barre Risk With RSV Vaccine Candidates
Ahead of a 2-day meeting with FDA’s vaccine advisors, reviewers at the agency highlighted a rare but potential risk for Guillain-Barré syndrome with two vaccine candidates for respiratory syncytial virus (RSV). On Tuesday and Wednesday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will recommend whether the risk-benefit profile with Pfizer and GSK’s vaccine […]
FDA Broadens Options for Relapsed/Refractory Multiple Myeloma With Teclistamab
Treatment options for relapsed/refractory multiple myeloma continue to expand with FDA’s accelerated approval of teclistamab (Tecvayli). The approval stipulates use of the bispecific antibody in adults who have received at least four prior therapies, including an immunomodulator, a proteasome inhibitor, and an anti-CD38 antibody (triple-class refractory disease). The first approved drug of its kind, teclistamab […]
Genetic Testing for Opioid Use Disorder Heads to FDA Advisors
On Thursday, members of the FDA’s Clinical Chemistry and Clinical Toxicology Devices Advisory Committee will meet to discuss AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD). AvertD detects the presence or absence of 15 single nucleotide polymorphisms (SNPs) to help identify adults with an increased genetic risk of OUD. It’s intended […]
Opinion | FDA Can Make Us Healthier Than ‘Healthy’
There’s been a lot of buzz over FDA’s move to redefine what can be labeled a “healthy” food. In a proposed rulemaking rolled out on the morning of the historic White House Conference on Hunger, Nutrition, and Health last month, FDA made some hefty claims about this long-awaited initiative. The agency predicted that redefining which […]
PI3K Inhibitor Fails to Pass Muster With FDA Advisory Committee
The FDA’s Oncologic Drugs Advisory Committee (ODAC) made a clean sweep of its 2-day meeting, deciding that the PI3K inhibitor duvelisib (Copiktra) does not offer a favorable risk-benefit ratio for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). By an 8-4 vote, the panel came down on the side of the FDA […]