Devices
FDA has cleared a United Imaging 510(k) for its first interventional X-ray system, uAngio Aviva. The company says the “intuitively bionic ceiling-mounted system” uses intelligent robotics, voice control, vision and imaging to assist clinical staff. United Imaging describes the eight-axis robotic system as offering flexibility to
Drugs
FDA’s Oncology Center of Excellence (OCE) has launched Project Interface, a new initiative aimed at deepening engagement with cancer patients, advocacy groups, and oncology professionals both in the U.S. and abroad. Under the theme “Making Cancer Personal at the FDA,” the initiative is designed to improve communication and
Biologics
U.S. health officials have issued a temporary pause on the use of Valneva's chikungunya vaccine Ixchiq in individuals aged 60 and older following reports of serious adverse events, including two deaths. FDA and CDC say they are investigating 17 cases of severe side effects reported globally in
Drugs
FDA has granted Beam Therapeutics a Regenerative Medicine Advanced Therapy designation for BEAM-302, a liver-targeting gene therapy designed to correct a disease-causing mutation in patients with alpha-1 antitrypsin deficiency (AATD). The inherited genetic disorder affects the lungs and/or liver, leading to early-onset emphysema and
Biologics
New CBER director Vinay Prasad says he is not “anti-vax” and promises that the Center will strive to “always strike the balance between data, evidence, innovation and entrepreneurial spirit of America.” In a 5/8-posted video conversation co-hosted by FDA commissioner Marty Makary and FDA Policy and
Drugs
FDA has granted MeiraGTx Holdings a regenerative medicine advanced therapy (RMAT) designation for AAV-GAD and its use for treating Parkinson’s disease not adequately controlled with anti-Parkinsonian medications. The investigational one-time infused gene therapy is designed to reprogram dysfunctional brain circuits through the local production of GABA,
FDA Policy/General
FDA is preparing to begin negotiation sessions in September to reauthorize the Prescription Drug User Fee Act (PDUFA), which expires 9/2027. A new notice is seeking public stakeholders — patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts — to participate in periodic consultation meetings. The agency is
Biologics
Appearing on MSNBC 5/9, FDA commissioner Marty Makary said discussions are continuing with Novavax on its BLA to convert a 2022 emergency use authorization to a full approval for its Covid-19 vaccine. The agency missed a user fee target date last month, which the company said was related
Drugs
Paradigm Therapeutics plans to file an NDA in the second half of this year for Zorblisa (SD-101), as a topical whole-body treatment for all subtypes of epidermolysis bullosa (EB) patients. “Epidermolysis Bullosa is a devastating disease,” the company says. “Results from the completed Phase 2 and Phase 3
Devices
FDA has approved a Teal Health PMA for the Teal Wand, the first at-home vaginal sample, self-collection device for cervical cancer screening. The prescription device is indicated for women aged 25–65 at average risk, according to the company. The at-home screening includes a collection kit and
Drugs
In what looks to be a common occurrence in the wake of recent downsizing and the subsequent departure of its leadership, FDA has now missed a 5/7 user fee review action target date for a GSK supplemental NDA for Nucala (mepolizumab) and its use as an add-on maintenance
FDA Policy/General
Speakers at the recent DTC National conference on direct-to-consumer advertising suggested that despite calls for a ban on consumer advertising by HHS secretary Robert F. Kennedy, Jr., the odds of such a ban being implemented remain low. Representing the Healthcare Advertising Coalition, Jim Potter discussed the legal and
FDA Policy/General
Former FDA commissioners Scott Gottlieb and Mark McClellan say a plan circulated by the Department of Health and Human Services to restructure FDA by consolidating the product Centers that review drugs, biologics, animal health, medical devices, and tobacco into a single regulatory office would face many challenges. Writing in an
Drugs
The FDA Office of Inspections and Investigations (OII) Ombudsman Program recommends that the agency explore developing a Stakeholder Education Hub, perhaps as a dedicated Web page that brings together existing educational resources organized around common concerns in a question-and-answer format. The recommendation is included in the program’s
Devices
FDA has given Orchestra BioMed the green light to begin a pivotal clinical trial evaluating its next generation Virtue Sirolimus-AngioInfusion Balloon (Virtue SAB) for treating coronary in-stent restenosis. The agency approved a study design amendment allowing a head-to-head trial comparing Virtue SAB to the only FDA-
Drugs
FDA has granted Italfarmaco a fast track designation to givinostat for treating patients with polycythemia vera (PV), a rare hematologic cancer. Givinostat is an orally administered histone deacetylase inhibitor (HDACi)with potential applications in both neuromuscular disorders and oncology, according to the company. “HDACis work by modulating key cellular pathways
FDA Policy/General
FDA commissioner Michael Makary says the agency will expand the use of artificial intelligence (AI)-assisted scientific reviews across all Centers by 6/30. In a statement, he says the rollout follows the successful completion of a new generative AI pilot for scientific reviewers. “I was blown away by the
Drugs
A northern Texas judge has ruled in FDA’s favor in a case challenging its decision last year to remove Eli Lilly’s weight loss and diabetes drugs Zepbound and Mounjaro from its drug shortage listing, a move that ultimately made it illegal for compounding pharmacies to produce large quantities
Devices
SS Innovations says it will seek a de novo marketing authorization in July for its SSi Mantra 3 surgical robotic system for multiple indications. The modular, multi-arm system is designed with many advanced technology features, according to the company, including three to five modular robotic arms, an open-faced
FDA Policy/General
The recent FDA reductions in force involving leadership, inspection administration, and travel logistical planners has been incredibly disruptive to the inspection cadre, but they do not rise to the level of disruption that was caused by the Covid-19 pandemic, former CDER Office of Compliance director (retired 2022) and now
FDA Policy/General
Theriva Biologics says its VCN-01 (zabilugene almadenorepvec) hit its endpoints in the VIRAGE Phase 2b trial using VCN-01 and standard of care (gemcitabine/nab-paclitaxel) as first-line therapy for patients with metastatic pancreatic ductal adenocarcinoma. A company statement says 48 patients treated with at least one dose
Biologics
Moderna Phase 3 research found that its investigational mRNA-1083 combination flu and Covid-19 vaccine demonstrated noninferiority and induced higher immune responses than the recommended standard of care flu and Covid-19 vaccines in adults aged 50 and older. The company reported its research in the Journal of the