FDA Policy/General
FDA is announcing a 10/14 Webinar on its recent draft guidance on Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics. The document details how drug developers can appropriately use Bayesian statistical methods in clinical trials intended to support approvals. FDA says Bayesian methods can play a
Drugs
Washington State University College of Pharmacy and Pharmaceutical Sciences affiliate professor Sarfaraz Niazi is petitioning FDA to extend the product-level, evidence-scaled logic reflected in its therapeutic-equivalence and biosimilar programs into a unified reference-anchored framework for follow-on human drugs and biological products. The petition says the
Biologics
FDA has approved a Janssen Biotech BLA for Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. The rare blood disorder causes a patient’s immune system to mistakenly attack and destroy
Biologics
An 11/17-12/16/2025 FDA inspection at the R3 Medical Companies’ Bello Bio and Regen Suppliers units in Scottsdale, AZ, documented that Bello contract manufactures and labels several umbilical cord-derived products and Regen approves, labels, stores, and distributes the Bello products and an umbilical cord product contract
Drugs
Friends of Cancer Research says it recently published two manuscripts supporting the use of circulating tumor DNA (ctDNA) as an early endpoint for regulatory decision-making. In a media release (contains links to the articles), the advocacy group says the manuscripts “show that on-treatment reductions in ctDNA levels are
Biologics
FDA has accepted for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for patients with previously untreated Stage II and III mismatch repair deficient/microsatellite instability-high locally advanced rectal cancer. The agency has set a user fee review action target date of 2/2027, according to the company,
Drugs
The Sedgwick Recall Index covering the first half of 2026 shows that the number of medical device recalls fell from 487 to 462 (down 5.1%), while the number of units recalled increased 516.8% from 50.7 million units in the first half of 2025 to 313.07 million
Drugs
Florence Healthcare says the FDA Expedited IND Pilot Program, part of the government’s Operation TrialBlazer, “takes the right premise seriously: that the United States cannot regulate its way past a site infrastructure problem.” In its response to the agency’s Request for Information, Florence’s comments relate to: * the
Biologics
HHS is seeking public input on how the federal government classifies vaccine recommendations, including whether its current system gives patients and parents enough choice and clearly reflects the strength of scientific evidence. A new Federal Register notice says the Department is reviewing three existing categories: routine recommendations, which generally apply
Biologics
FDA has placed a clinical hold on Regenxbio's investigational gene therapy RGX-121 after asymptomatic spine MRI findings were identified in five participants in a clinical trial evaluating the treatment for Hunter Syndrome or Mucopolysaccharidosis Type II (MPS II). In response, the company says it does not expect
Drugs
As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., a new study using a U.S. rheumatology registry has found that while liver enzyme elevations were uncommon among patients treated with avacopan, it identified two cases of drug-induced liver injury (DILI), including
Devices
FDA has cleared Roche/Eli Lilly’s Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test as a single blood-based option to aid in identifying amyloid pathology associated with Alzheimer's disease in individuals 55 years and older with signs, symptoms, or complaints of cognitive decline. The companies say
Devices
FDA has issued an early alert about a potentially high-risk problem involving certain CooperSurgical INCA neonatal and infant nasal continuous positive airway pressure (CPAP) sets that may develop a loose connection between the tubing and nasal cannula. Earlier this month, the company sent affected customers a letter recommending that
Biologics
FDA has extended by three months its review of a Capricor Therapeutics BLA for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD). The new user fee review action target date is 11/22. “As part of its ongoing discussions with the FDA following the July 2026 Advisory Committee
Biologics
CBER has updated its standard operating procedures for resolving scientific/procedural disputes between sponsors and the Center, establishing revised procedures and adding medical devices to the formal dispute resolution process. The updated SOPP 8005: Formal Dispute Resolution Process applies to disputes between sponsors and CBER review staff involving regulatory submissions.
Drugs
House Select Committee on China chairman John Moolenaar (R-MI) and Rep. Ben Cline (R-VA) are urging FDA intensify safeguards on clinical trial data generated in China, citing concerns about transparency and potential underreporting of serious adverse events and patient deaths. In an 8/20 letter to acting FDA
Drugs
Scholar Rock said Friday that it has made further regulatory progress for apitegromab, its investigational treatment for spinal muscular atrophy (SMA), removing a troubled Catalent (part of Novo Nordisk) facility from its BLA resubmission. The facility removal was recommended by FDA after Scholar added a second U.S.-based fill-
Devices
CDRH is issuing an Early Alert after becoming aware that GE HealthCare issued a letter alerting affected customers of updated use instructions for Portrait Mobile Monitoring Solutions devices operating on certain version of Portrait Core Services software. The alert recommends that users ensure “appropriate alternative monitoring is established for patients
Drugs
FDA has issued a final guidance describing how it evaluates therapeutic equivalence among prescription drug products and assigns therapeutic equivalence codes in the agency’s Approved Drug Products With Therapeutic Equivalence Evaluations (aka, the Orange Book). The document, “Evaluation of Therapeutic Equivalence,” describes the scientific and regulatory principles the agency
Devices
Boston Scientific has recalled its ENROUTE Transcarotid Neuroprotection System Plus, a single-use percutaneous catheter kit used during transcarotid artery revascularization. The device is intended to provide direct carotid access and dynamic blood flow reversal to capture loose plaque debris, protecting the brain from strokes during carotid stenting. An FDA
Devices
Medline has issued a device correction (Class 1 recall) for convenience kits containing B. Braun’s bupivacaine hydrochloride components. An FDA notice says Medline issued a letter to affected customers recommending that certain Medline convenience kits be corrected prior to continued use by removing components affected by the B. Braun
Devices
FDA Digital Health Center of Excellence director Rick Abramson says that digital health technologies (DHTs), especially those enabled by artificial intelligence, can continuously capture information about a person’s health in real time and in the context of their everyday life. Writing in an FDA Voices column, Abramson says DHTs