This Week at FDA: HHS considering new FDA posts, FDA approves slew of firsts, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. According to news reports, the Trump administration may create two more FDA executive positions in a possible bid to exert more control over the agency; FDA approved several first-of-its-kind treatments, including a drug that was approved well ahead of its decision date and a wearable device that tracks ketones and glucose levels.

CNBC reported that the Department of Health and Human Services is planning to create two new FDA deputy commissioner positions: one focused on technology and the intersection of health and artificial intelligence, and another for drugs. While no final decision or formal announcement has been made, the outlet’s anonymous sources noted that the move is intended to allow the Trump administration to exert more influence over the agency.

Revolution Medicines' Rasonque (daraxonrasib), a RAS inhibitor, was approved by the FDA as the first targeted therapy to treat metastatic pancreatic cancer, the most common form of pancreatic cancer. "This drug showed unprecedented results in an area of high unmet need," said Angelo de Claro, director of the FDA Oncology Center of Excellence. "The approval was granted 6.5 months before the user fee deadline, demonstrating the FDA’s commitment to accelerating the approval of new cancer treatments for patients with serious and life-threatening conditions."

Priovant Therapeutics' Lisraya (brepocitinib) was approved by FDA as the first oral treatment for dermatomyositis, a rare autoimmune disease. The agency noted that until now, patients with the disease often had to rely on treatments originally intended for other diseases.

Janssen Biotech's Imaavy (nipocalimab-aahu) was approved by FDA as the first drug to treat warm autoimmune hemolytic anemia (wAIHA) in patients aged 12 years and older who are currently being treated with corticosteroids or have previously been treated with corticosteroids. The agency noted that wAIHA is a rare blood disorder and the most common type of autoimmune hemolytic anemia that affects about 1 to 3 people per 100,000 a year.

FDA announced it is withdrawing a slew of product-specific guidances while also publishing new and revised draft product-specific guidances. Interested parties can comment on the guidances through 23 October.

Drugs & Biologics

The Center for Biologics Evaluation and Research (CBER) Office of Blood Research and Review will host a roundtable on 29 September to discuss ways to strengthen the supply chain for the collection and manufacturing of whole blood and blood components for transfusion. The day-long event will be divided into three sessions focusing on current challenges in the blood manufacturing supply chain; manufacturers’ perspectives on the root causes of supply chain disruptions and possible solutions; and how federal agencies can help strengthen and build resilience in the supply chain.

ViiV Healthcare's Tivicay PD (dolutegravir) was approved to treat human immunodeficiency virus (HIV) infections in babies from birth to 4 weeks weighing at least 2 kg, in combination with other antiretroviral agents. The agency noted that Tivicay and Tivicay PD are already approved for adults and children older than 4 weeks.

FDA issued a statement asking compounders not to use dietary supplement-grade glutathione for injectables. The agency said it has received reports of at least 30 patients who suffered adverse events after being administered intravenous (IV) glutathione or in combination with other ingredients that were made by compounding pharmacies that obtained their glutathione from New York-based Medisca.

Medtech

Abbott's Libre Duo 10 Day continuous dual glucose and ketone monitoring system for patients 2 years and older with diabetes has been granted de novo authorization by FDA. The agency said it is the first wearable device in the US to continuously monitor ketone levels, and the first in the world to continuously monitor both ketones and blood sugar in a single device.

The Center for Devices and Radiological Health (CDRH) is seeking public feedback on which accessories it should consider for distinct classification as Class I medical devices. Stakeholders have until 16 October to give their feedback to the agency.

FDA published the latest Medical Device User Fee Amendments (MDUFA) quarterly performance report, which shows that the average time for premarket approval (PMA) decisions dropped from 333 days to 248 days in 2025, largely due to shorter manufacturer times during the review process. The data, however, does not include almost 3% of reviews opened in 2024 and almost 18% opened in 2025.

After announcing its READI-Home challenge as part of the Health Care Hub Initiative in June to help develop medical devices that can reduce hospital readmissions,

FDA announced that Epitel and Prapela are the first two companies to participate in the READI-Home Innovation Challenge, a part of the agency’s Health Care Hub Initiative.

Epitel is developing the REMI Neuro Monitoring Home Health Hub, a wireless wearable electroencephalography (EEG) system, while Prapela is developing the Prapela Therapeutic Vibrational Crib Mattress, a crib mattress intended to reduce the frequency, duration, and severity of hypoxemic and bradycardic episodes in infants with single-ventricle heart disease (SVHD).

FDA has issued an early alert for Abiomed's Automated Impella Controllers due to reports that the purge cassette may not be recognized, which, the company reported, has led to 37 serious injuries and three deaths. The company said it would replace components to fix the issue either through annual preventive maintenance or by contacting customers individually.

FDA also issued an early alert for Braco CF esophageal pH monitoring capsule delivery devices made by Medtronic and its subsidiary, Given Imaging, due to concerns that the capsule may not attach to the patient’s esophagus or detach from the delivery device as intended. The agency said that Medtronic has reported 184 serious injuries related to the issue so far.

Boston Scientific has issued a Class I recall for its ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus due to reports that the arterial sheath tip may fully or partially separate during use. FDA said the company has so far reported one serious injury related to the issue.

AVID Medical has issued a Class I recall for certain convenience kits containing Medline Namic Star Off Handle Manifolds. Medline itself issues a Class I recall after finding particulates in the fluid path of the manifolds.

FDA issued a safety alert to patients who had mammograms at the Mammography Center of Monterey (CA), on or after 22 December 2023, due to concerns about the quality of the mammograms taken at the center. The agency noted that the center failed to comply with reporting requirements, which ultimately led the American College of Radiology (ACR) to revoke its accreditation.