Drugs
FDA has approved a Novartis NDA for Rhapsido (remibrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor for treating adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine therapy. Taken as a twice-daily pill, Rhapsido is designed to block BTK, a protein that activates immune cells responsible for
Devices
CDRH has published a list of 11 guidances it expects to issue in FY 2026. The list contains an A-List (priority to publish) with four final guidances and four draft guidances. A B-List (publish as resources permit) has three final guidances and no drafts. For the first time,
FDA Policy/General
As the government shutdown went into effect 10/1, FDA commissioner Marty Makary told employees that the agency will continue mission-critical activities necessary to protect public health until the budget impasse is resolved. This means the agency is directed to respond to foodborne illness outbreaks, manage high-risk food
Biologics
AbbVie 9/30 submitted a BLA seeking approval for its investigational antibody-drug conjugate pivekimab sunirine (PVEK) to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive blood cancer. The submission is based on data from AbbVie’s global Phase 1/2 CADENZA trial, which evaluated the safety
FDA Policy/General
The Washington Legal Foundation (WLF) says FDA’s recent “crackdown” on direct-to-consumer television advertising runs counter to First Amendment protections for commercial speech that is truthful and non-misleading. A 9/29 letter to the agency cautions that challenges to the agency’s “thousands” of Warning Letters and
Drugs
FDA has published the eight FY 2026 Generic Drug User Fee Act science and research priority areas. The list was developed after a 6/3-6/4 public workshop to gather input on the priorities, a notice says. The agency says the eight priority areas “encompass scientific challenges that the
Devices
FDA has cleared a UroViu 510(k) for its UV5000 cordless, single-use endoscope platform. The new device, which replaces the UV4500 currently on the market, is designed to improve clinical efficiency with a faster processor, longer battery life, and brighter high-definition visualization, according to the company. UroViu says
Drugs
A Bioresearch Monitoring Program inspection at a clinical site operated by Pamela Den Besten, DDS, in San Francisco, CA, found that she failed to submit an IND for the conduct of a clinical investigation with an investigational new drug. A 9/19 Warning Letter says Den Besten conducted a study
Drugs
A 1/27-2/26 FDA inspection at the Persōn & Covey drug manufacturing facility in Glendale, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. The inspection also found that two of the firm’s drug products are legally considered to be unapproved new
Drugs
CDER director George Tidmarsh has questioned the use of surrogate endpoints and has publicly attacked Aurinia Pharmaceuticals’ Lupkynis (voclosporin), which was approved in 2021 for treating lupus nephritis. In an unprecedented and now-deleted LinkedIn post, Tidmarsh claimed that voclosporin has “significant toxicity” and has not been shown to have
Drugs
In the 16 months since its founding, the CDER Quantitative Medicine Center of Excellence (QM CoE) says it has achieved “significant accomplishments” in three strategic areas — enterprise planning and coordination, applied regulatory science, and education and ecosystem development. A QM CoE Progress and Priorities Update says the Center of Excellence
FDA Policy/General
FDA would experience sharp reductions in operations if Congress fails to reach a deal to fund the government and avert an ensuing shutdown, which now seems likely to occur beginning 10/1, according to contingency plans released by HHS. While critical safety functions and some drug and device reviews funded
Devices
FDA has approved a Zoll Medical PMA for Zenix, the company’s newest monitor/defibrillator, which it says is designed to streamline emergency and hospital care. The device features a large touchscreen and customizable settings that allow healthcare professionals to adjust functions in real time. Among its key features are
Drugs
FDA researchers say that while much more work is needed, the Office of New Drugs (OND) specialized term grouping system for adverse event analysis, known as OND Custom Medical Queries (OCMQ), has been useful in premarket drug safety evaluation. Writing in the open-source journal Drug Safety, the researchers say
Drugs
FDA has posted an International Council for Harmonization draft guideline entitled E20 Adaptive Designs for Clinical Trials that provides recommendations on using adaptive designs in confirmatory clinical trials. The guideline lays out principles to help sponsors ensure that such trials produce reliable and interpretable evidence to support benefit-risk assessments
Devices
FDA has issued an updated alert about an ongoing Class 1 recall of certain BD Alaris Pump Module infusion sets, warning that continued use of the affected devices could cause serious injury or death. The recall involves performance issues with the BD Alaris Pump Module model 8100 when used with
FDA Policy/General
FDA commissioner Marty Makary has told agency employees that they are protected from planned mass workforce firings if a government shutdown goes into effect 10/1. “I want you to know that would not apply to the FDA,” Makary said in a 30-second video reported by Bloomberg Law that
Drugs
FDA released a draft guidance to help drugmakers design clinical trials for treatments targeting disseminated coccidioidomycosis, also known as Valley Fever, a fungal disease caused by Coccidioides species. The document outlines the agency’s current thinking on trial designs, patient populations, and efficacy endpoints for evaluating potential therapies. Coccidioidomycosis is
Drugs
Larimar Therapeutics has reported encouraging long-term data from its open-label study of nomlabofusp, an investigational therapy for Friedreich’s ataxia (FA), while confirming plans to seek accelerated FDA approval in the second quarter of 2026. The study, which is evaluating daily subcutaneous doses of nomlabofusp in adolescents and
Biologics
Novo Nordisk has resubmitted a BLA for Awiqli (insulin icodec), a once-weekly basal insulin injection for adults with Type 2 diabetes. If approved, the company says Awiqli would become the first once-weekly basal insulin available in the U.S., offering an alternative to daily injections. The resubmission follows
Biologics
IO Biotech says it has recently been advised by FDA not to submit a BLA for its experimental cancer vaccine Cylembio based on results from a recently completed Phase 3 trial in advanced melanoma. The FDA input came during a pre-BLA meeting at which the agency concluded that data
Devices
FDA has expanded its medical device “Early Alert” program to cover all products that may pose significant safety risks. CDRH launched the pilot program 11/2024 and it applied to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology device issues. It was designed to reduce the lag between when