Drugs
Regeneron’s FDA delays in getting two regulatory submissions approved for Eylea HD (aflibercept) injection 8 mg are shedding light on the extent of problems being uncovered in agency inspections at the plant that manufactures the product. Earlier this week, the company announced the delay in reviewing these because information
Devices
FDA has cleared a Signos 510(k) for what the company says is the first over-the-counter glucose monitoring system designed specifically for weight management. The device pairs Dexcom’s Stelo glucose biosensor with Signos’ artificial intelligence-driven platform to provide consumers real-time insights into how diet, exercise,
Drugs
FDA says it will now publish drug safety data on a daily basis, a shift the agency says will give the public faster access to information about adverse events tied to prescription drugs and biologics. The move marks a major change to FDA’s Adverse Event Reporting System (FAERS), which
Drugs
FDA has accepted for review a Stealth BioTherapeutics NDA resubmission for elamipretide for treating Barth syndrome. The agency is considering the submission a Class 2 response with a six-month user fee goal date of 2/15/2026, but it has told Stealth that a decision will be made by
Drugs
Nicox says it will submit an NDA early next year after new data from its DENALI Phase 3 study of glaucoma therapy NCX 470 showed promising results. The study, which enrolled 696 patients with open-angle glaucoma or ocular hypertension across 90 sites in the U.S. and China, showed
Devices
Researchers from several academic medical centers say that only half of artificial intelligence (AI)- and machine learning (ML)-enabled devices authorized by FDA for Alzheimer’s disease and related dementias (ADRD) have demographic details reported for their training or validation datasets. Writing in a JAMA Research Letter, the authors say
Drugs
FDA has approved an Ionis Pharmaceuticals NDA for Dawnzera (donidalorsen) as the first RNA-targeted prophylactic treatment for hereditary angioedema (HAE) in patients 12 years and older. The drug is designed to block plasma prekallikrein, a protein that drives the inflammatory force behind HAE attacks, according to the company. The
Drugs
AbbVie is reporting that its JAK inhibitor Rinvoq (upadacitinib) met primary and secondary endpoints in a pivotal Phase 3 study testing the drug in patients with severe alopecia areata (AA). The company says that its Study 1 of the UP-AA program saw 45.2% of patients receiving a 15
FDA Policy/General
A deeply-reported “groundbreaking” ProPublica analysis of HHS workplace statistics finds that 21% of FDA staff have left the agency, either through reductions in force or voluntary retirements and resignations. The report says HHS did not dispute its analysis and its conclusion that over 20,500 HHS employees are no
Drugs
Officials in 14 states (13 attorneys general and one governor) say they are joining four other states in their petition to FDA, asking the agency to eliminate the mifepristone REMS program that controls access to the drug that is the most common means of abortion in the U.S. In
Drugs
FDA has granted Keros Therapeutics an orphan drug designation for its investigational therapy KER-065 and its use in treating Duchenne muscular dystrophy. The company says it is preparing to launch a Phase 2 trial of the therapy. Keros describes KER-065 as a ligand trap designed to block signaling
Devices
FDA has published a guidance, Animal Studies for Dental Bone Grafting Material Devices, with 510(k) recommendations for animal studies that may assist manufacturers in complying with some special controls for dental bone grafting material devices. The document says the recommendations reflect current practices and are intended to promote consistency
Drugs
FDA has published a draft guidance, Approaches to Assessment of Overall Survival in Oncology Clinical Trials, with recommendations for sponsors on assessing overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a
Biologics
FDA is announcing a 10/23 public workshop to discuss the regulatory status of patch tests used in diagnosing allergic contact dermatitis (ACD). The CBER-directed one-day virtual event is intended to gain stakeholder input on current approval requirements and potential alternative approaches. Patch testing is the only validated
Drugs
Contract development and manufacturing organization Nucleus RadioPharma has appointed former FDA commissioner Stephen Hahn (Trump Administration 2019-2021) as its chief executive officer. Hahn joins Nucleus after serving as CEO-partner of Flagship Pioneering and CEO of Harbinger Health since 2021. Before joining FDA, he was the chief medical executive
Devices
FDA has issued enVVeno Medical a not-approvable letter for its PMA on VenoValve, a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency (CVI). The agency concluded that data submitted from the SAVVE study were insufficient to establish a favorable benefit-risk profile, the company says.
Biologics
FDA has lifted a clinical hold on Rocket Pharmaceuticals’ pivotal Phase 2 trial of RP-A501, an investigational gene therapy for Danon disease, allowing the study to resume less than three months after being paused. The hold followed the death of a participant who experienced serious complications during the study.
Biologics
Experts interviewed for an online Clinical Trials Arena post have differing opinions on the impact of a recent FDA rule barring new clinical trials that involve sending U.S. citizens’ living cells to China and other “hostile” countries for genetic engineering before they are returned to be infused into the
FDA Policy/General
More than 750 current and former HHS staffers have signed an 8/20 letter calling on HHS secretary Robert F. Kennedy, Jr., to “stop spreading inaccurate health information” in the wake of an 8/8 shooting at the Atlanta, GA, headquarters of the Centers for Disease Control. CNN reports that
Devices
Since its 2015 inception, the FDA Breakthrough Devices program has granted 1,176 breakthrough device designations, 1,157 from CDRH and 19 from CBER. Updated program metrics also show that the agency has granted 160 marketing authorizations since 2015.
Devices
FDA has suggested possible ways forward for CytoSorbents’ DrugSorb-ATR after denying the company’s appeal of the agency’s 4/25 denial of a de novo application for the antithrombotic removal system. In denying the appeal, FDA said it found no issues with device safety, a company statement says,
Drugs
Writing on behalf of an unnamed client, Wiley Rein is petitioning FDA to take “specific and necessary actions to address the significant and escalating public health risks associated with the large-scale production and distribution of compounded drug preparations purporting to contain semaglutide.” The petition asks for these specific FDA