Drugs
Edwards Lifesciences has recalled (Class 1) its Optisite Arterial Cannula due to complaints received about its 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. The company says the device provides or establishes arterial perfusion in the extracorporeal circuit. The company recently sent a recall
Biologics
FDA is currently conducting benefit-risk modeling studies based on the evolving risk of Covid-19 severe outcomes and the long-term cardiac damage from vaccine-associated myocarditis, agency leaders say in a new JAMA article that outlines their rationale in ordering recent safety labeling change to mRNA Covid vaccines.
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Winrevair (sotatercept-csrk), seeking to update the drug’s U.S. label to include data from the Phase 3 ZENITH trial, which demonstrated a significant reduction in mortality and morbidity among patients with pulmonary arterial hypertension (PAH). Approved in
Drugs
FDA has issued Capricor Therapeutics a complete response letter on its BLA for Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The letter cited a lack of “substantial evidence of effectiveness” and called for additional clinical data, according to the company, adding that it also
Drugs
FDA has cleared an Intuitive 510(k) for its Vessel Sealer Curved advanced energy instrumentation for use with its multiport da Vinci systems. The device is described by the company as a “fully wristed, advanced bipolar electrosurgical instrument designed to seal, cut, grasp, and dissect tissue,” such as for transection
Biologics
FDA is announcing a 9/19 scientific workshop to discuss the development of interchangeable biosimilar products to help identify future needs (e.g., guidance, research). The agency says the meeting agenda includes presentations by representatives from the biosimilar industry on the future needs for the development of interchangeable products, discussions
Drugs
A day after releasing hundreds of past complete response letters (see earlier story) as part of FDA’s “radical transparency” efforts, FDA commissioner Marty Makary is now pledging to release newer letters in “real time.” Addressing criticism by some FDA watchers that the letters were too old to be useful
Devices
FDA has granted Artera a breakthrough device designation for its ArteraAI Prostate, an artificial intelligence-based tool designed to assist clinicians in personalizing treatment decisions for patients with localized prostate cancer. The company says the device’s software uses multimodal artificial intelligence to analyze digital pathology images from a patient’
Drugs
FDA has accepted for review a Milestone Pharmaceuticals NDA resubmission for Cardamyst (etripamil) nasal spray, a self-administered treatment for paroxysmal supraventricular tachycardia (PSVT). The agency has set a user fee review action target date of 12/13. The resubmission addresses a March FDA complete response letter and includes the
Drugs
Avanos Medical is recalling (Class 1) its Ballard Closed Suction Systems due to a failure in the sterilization process. “Use of the affected product may cause serious adverse health consequences, including infection, airway injury, prolonged inflammation, sepsis, or death,” a recall notice says. To date, Avanos says it has not
Drugs
FDA says it is demonstrating “radical transparency” with the publication of over 200 complete response letters (CRLs) issued between 2020 and 2024. The letters were issued in response to applications for approval of new drugs or biologics. An agency statement (contains a link to the letters) says the public “now
FDA Policy/General
FDA commissioner Martin Makary marked his 100th day on the job with a statement celebrating “the agency’s accomplishments in the bipartisan effort to Make America Healthy Again.” The statement says that in the past 100 days, FDA has launched dozens of key initiatives across the full range of the
Drugs
FDA has accepted for review a Merck NDA for its investigational once-daily HIV treatment combining doravirine and islatravir (DOR/ISL). The two-drug regimen is intended for adults with HIV-1 infection who are already virologically suppressed on existing antiretroviral therapy. The agency has set a user fee review
FDA Policy/General
The Senate Committee on Appropriations 7/10 voted (27 to 0) to approve and advance to a floor vote the Fiscal Year 2026 Agriculture, Rural Development, FDA and Related Agencies Appropriations Act. The bill would provide $3.6 billion in discretionary budget authority and $3.4 billion in user fees,
Biologics
FDA has approved a Moderna sBLA for Spikevax, the company’s Covid-19 vaccine, in children aged six months through 11 years who are at increased risk for Covid-19 disease. A company statement says the FDA full approval replaces the previous emergency use authorization.
Drugs
The House Energy and Commerce Committee Health Subcommittee has scheduled a 7/16 public hearing titled “Legislative Proposals to Maintain and Improve the Public Health Workforce, Rural Health, and Over-the-Counter Medicines.” Energy and Commerce Committee chair Brett Guthrie (R-KY) and Health Subcommittee chairman-designate Morgan Griffith (R-
Devices
AirLife is recalling certain lots of its Broselow Pediatric Emergency Rainbow Tape because they were manufactured with incorrect information on the tape. “Incorrect joules in the cardioversion and defibrillation section are printed in the red zone of the tape,” a recall notice says. “Using the incorrect information in this section
Drugs
FDA has approved an updated dosing schedule for Eli Lilly’s Alzheimer’s therapy Kisunla (donanemab-azbt), aimed at reducing the risk of a known side effect called amyloid-related imaging abnormalities with edema (ARIA-E). Approved 7/2024 as a once-monthly infusion therapy targeting amyloid plaques in the
Drugs
A 12/3-12/6/2024 FDA inspection at the Dynamic Blending Specialists drug manufacturing facility in Vineyard, UT, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 6/15 Warning Letter says the specific violations were: * failure to conduct at least one
Drugs
A 3/11-3/14 FDA inspection at the Libby Laboratories drug manufacturing facility in Berkeley, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/27 Warning Letter says the specific violations were: * failure to conduct for each batch of drug product, appropriate
Devices
A University of Illinois law school scholar who specializes in the ethical and legal challenges of artificial intelligence (AI) for health care says FDA needs to develop labeling standards for AI-powered medical devices. A university news release says Sara Gerke suggests that the labeling follow the format of mandatory
Devices
The Foundation for Defense of Democracies (FDD) says that medical devices such as pacemakers, insulin pumps, and vital signs monitors that are already in use in healthcare settings are vulnerable to hacking despite a new FDA guidance. An FDD paper says the guidance doesn’t have a requirement that companies