Drugs
The U.S. Court of Appeals for the Fifth Circuit has upheld FDA’s decision to remove tirzepatide from the agency’s drug shortage list, a ruling that limits the ability of pharmacies and compounding facilities to produce versions of the popular drugs. The case involved Eli Lilly’s Mounjaro
Drugs
The Biotechnology Innovation Organization (BIO) says it agrees with FDA that it is critical to shorten the time it takes from drug identification to first-in-human study. In a comment letter, BIO says the agency’s proposed pilot for an expedited Investigational New Drug (IND) “presents a timely opportunity
Drugs
Rep. Lauren Boebert (R-CO) has introduced the Advancing Botanical Drug Development Act of 2026, which she says would expand treatment options for chronic, complex and age-related diseases while maintaining existing FDA safety and efficacy requirements. In a statement, Boebert says her legislation “would address the barriers to late-
Drugs
FDA has approved Revolution Medicines’ Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer — providing a new treatment option to patients with advanced pancreatic cancer 6.5 months ahead of the user fee review action target date. The once-a-day tablet “targets multiple forms of
Drugs
Celcuity has submitted a supplemental NDA for Revtorpyk (gedatolisib) for treating patients with hormone receptor positive, human epidermal growth factor receptor 2 negative (HER2-), locally advanced or metastatic breast cancer (ABC) with a PIK3CA mutation, following progression on or after treatment with at least one line of endocrine therapy. Last
Drugs
One of the key takeaways from a 4/23 meeting convened by FDA and the Duke Margolis Institute for Health Policy to discuss increasing access to nonprescription drugs was the recognition that additional efforts may be necessary to capture information on nonprescription drug use in electronic health records or via
Devices
FDA says the Boston Scientific 7/9 recall of its ENROUTE Transcarotid Neuroprotection System is Class 1. An agency notice says the company notified customers that the affected devices should be removed from where they are used or sold. The ENROUTE Transcarotid System reportedly is designed to transport emboli away
FDA Policy/General
HHS is planning to name an FDA deputy commissioner for technology and a deputy commissioner for drugs, according to a CNBC report. The network says some anonymous sources in the Trump administration see the new appointments as a way to exert greater influence over the agency. Both of the new
Drugs
Two physicians affiliated with Stanford University’s medical school are urging FDA to approve carbetocin for preventing postpartum hemorrhage, arguing that the drug could provide a longer-lasting alternative to currently available uterotonic medications. In an 8/25 citizen petition, Kenneth Nguyen and Pervez Sultan asked FDA to approve carbetocin
Devices
CDRH is issuing an early alert to notify the public about an Abiomed action recommending that all Automated Impella Controllers (AIC) be removed from where they are used or sold. The removal is due to “purge cassette recognition issues resulting from failures of the purge flag component within the purge
Drugs
The American Society of Clinical Oncology/Association for Clinical Oncology (ASCO) says its members have reported critical supply disruptions of ifosfamide, leaving some practices with less than a few weeks of inventory. An ASCO statement says that with no direct substitute for this essential chemotherapy agent, practices are urged to
Devices
FDA has granted Abbott Diabetes Care a de novo authorization for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged two years and older living with diabetes. The agency says the device is the first wearable in the U.S. to continuously monitor both ketones
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