MedPage Today

Trump's New Surgeon General Pick Has Both Praised and Cringed at His Administration

Nicole Saphier, MD, is President Donald Trump's latest pick for the vacant role of U.S. surgeon general, a nomination that ended the embattled campaign of his previous candidate, Casey Means, MD, after it became clear she didn't have the votes to advance out of a Senate committee. Saphier, a radiologist and former Fox News Channel contributor, has promoted several aspects of Health Secretary Robert F. Kennedy Jr.'s Make America Healthy Again (MAHA) agenda, including removing food additives, cutting ultraprocessed foods from diets, and encouraging exercise. But she has been a more vocal advocate for vaccination than Kennedy, and at times she has criticized the Trump administration's handling of health issues as "embarrassing." If confirmed as the nation's doctor, Saphier would be empowered to issue advisories that warn of public health threats. Surgeons general also have used the office to advocate on vaccination issues -- though the office doesn't create vaccine policy. Means, a Stanford University-educated physician and MAHA influencer who didn't finish her surgical residency in Oregon and has an inactive medical license, had faced a grilling from senators of both major political parties over her experience and stance on vaccination. She told the Associated Press her failed nomination was

Court Restricts Abortion Access Across U.S. by Blocking the Mailing of Mifepristone

A federal appeals court has restricted access to one of the most common means of abortion in the U.S. by blocking mailing of mifepristone prescriptions. The unanimous ruling Friday from a three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals requires that the abortion pill be distributed only in person and at clinics, overruling regulations set by the FDA. The ruling, which is likely to be appealed to the U.S. Supreme Court, is the biggest jolt to abortion policy in the U.S. since the 2022 Supreme Court ruling that overturned Roe v. Wade and allowed states to enforce abortion bans. In the ruling, Judge Kyle Duncan, who was appointed by President Donald Trump, agreed with the state of Louisiana's contention that allowing the drug to be mailed there makes moot the state's ban on abortion at all stages of pregnancy. "Every abortion facilitated by FDA's action cancels Louisiana's ban on medical abortions and undermines its policy that 'every unborn child is human being from the moment of conception and is, therefore, a legal person,'" the ruling states. Mifepristone is involved in most abortions in the U.S. It was approved in 2000 as a safe and effective way

Hereditary Angioedema Prophylaxis: Persistence and Adherence

Advances in hereditary angioedema attack prophylaxis have provided more options for patients than ever before, with multiple agents available for long-term prevention. "The treatment landscape for hereditary angioedema is evolving rapidly, with several long-term prophylaxes approved in the last decade," and more on the horizon, said William Lumry, MD, of AARA Research Center in Dallas. "Over time the treatment burden has gone down significantly. ... And now we're starting to see more extended-interval drugs." These preventive medications include:C1 esterase inhibitor (Haegarda) approved in 2017 for subcutaneous injection every 3-4 daysPlasma kallikrein inhibitor lanadelumab (Takhzyro) approved in 2018 for subcutaneous injection every 2-4 weeksPlasma kallikrein inhibitor berotralstat (Orladeyo) approved in 2020 as a once-daily oral capsuleAnti-factor XIIa biologic garadacimab (Andembry) approved in 2025 for subcutaneous injection once monthlyRNA-targeted therapy donidalorsen (Dawnzera) approved in 2025 for subcutaneous injection every 4 or 8 weeks And real-world data show that patients are taking advantage of those options, sticking with a medication typically less than 2 years. Those were the findings Lumry reported from an observational study presented in March at the American Academy of Allergy, Asthma & Immunology annual meeting. His analysis of the Komodo Research Database of insurance claims to more than 150

First-in-Class Vepdegestrant Approved in Advanced Breast Cancer

— Oral agent in second-line more than doubled median PFS in patients with ESR1 mutations May 1, 2026 • 2 min read The FDA approved oral vepdegestrant (Veppanu) for adults with advanced or metastatic estrogen receptor (ER)-positive/HER2-negative breast cancer, the agency announced on Friday. Approval of the first-in-class proteolysis targeting chimera (PROTAC) -- a type of heterobifunctional protein degrader therapy -- stipulates use in patients with ESR1-mutated disease that has progressed following at least one line of endocrine therapy. Findings of the global phase III VERITAC-2 trial showed that among patients with ESR1-mutated disease, vepdegestrant reduced the risk of disease progression or death by 43% compared with fulvestrant (Faslodex), with a median progression-free survival (PFS) of 5 months versus 2.1 months, respectively (HR 0.57, 95% CI 0.42-0.77, P=0.0001). "For patients living with ESR1 mutant, [ER-positive/HER2-negative] advanced breast cancer, there have been minimal second-line treatment options once standard therapies are no longer effective," investigator Erika Hamilton, MD, of the Sarah Cannon Research Institute in Nashville, Tennessee, said in a press release from drugmaker Arvinas. "The introduction of a new, targeted treatment is an encouraging development for this community and highlights meaningful innovation in the way this disease is treated," Hamilton added.

As RFK Jr. Downplays Rabies, CDC Staff Tells Docs It's a Daily Threat

Just a week after Health Secretary Robert F. Kennedy Jr. downplayed rabies during a Senate hearing based on the few annual fatalities, CDC staff held a call with physicians to emphasize that preventing further deaths requires millions of U.S. medical visits every year along with 100,000 preventive vaccinations. In an online seminar for clinicians on Thursday, a CDC official offered guidance on accurately preventing a dangerous viral infection that has an effective yet costly postexposure prophylaxis (PEP) vaccine but no FDA-approved treatment. The rabies virus attacks the central nervous system and causes progressive, fatal inflammation of the brain and spinal cord. Humans are typically infected via saliva from bites or scratches by infected mammals such as dogs, bats, skunks, or raccoons. Without timely PEP before symptom onset, infection is fatal. Worldwide, rabies causes an estimated 59,000 deaths annually. However, since 2000 the CDC has received only 1 to 8 reports per year of rabies-related human deaths in the U.S., in large part because of widespread canine vaccination. Two such deaths happened in 2024 in Minnesota and California, both following encounters with bats. Neither patient reported their bat encounter, and both failed to seek medical attention before the onset of rabies

Nearly 30 Serious Injuries Tied to Recalled Insulin Pods, FDA Says

— Small internal tears in Omnipod 5 insulin pump pods could lead to underdosing May 1, 2026 • 2 min read Omnipod 5 insulin delivery pods subject to a class I recall have been linked to nearly 30 serious injuries, the FDA said on Thursday. The agency reiterated that patients should not use pods from 49 affected lots that may have a small tear in the internal tubing, which may cause insulin to leak inside the pod, leading to under-delivery of medication. When the voluntary recall was initiated on March 12, manufacturer Insulet had received 18 reports of serious adverse events tied to hyperglycemia, including hospitalization and diabetic ketoacidosis (DKA). As of April 17, Insulet has reported 29 serious injuries and no deaths associated with this issue, the FDA said. (An agency communication on Wednesday erroneously reported the number of serious injuries; that number has since been corrected.) "If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin," the FDA said. "In the most severe cases, prolonged and persistent high blood glucose levels can lead to DKA, a serious medical condition that requires prompt medical treatment and can be life-threatening if not

Brain Changes Linked to Ultraprocessed Foods, Even in Otherwise Healthy Diets

A 10% increase in ultraprocessed food intake was tied to lower attention scores and greater dementia risk in a cross-sectional study.The relationships persisted even in people who followed a Mediterranean diet.No relationship emerged between ultraprocessed food intake and memory scores. People who included more ultraprocessed foods -- chips, candy bars, frozen meals, sugary cereals, or soda, for example -- in an otherwise healthy diet had worse attention scores and a higher risk of dementia, an analysis of cross-sectional data in Australia suggested. Each 10% increase in ultraprocessed food intake was associated with a 0.05-point decrease (95% CI -0.09 to -0.01, P=0.012) in composite attention scores among adults 40 and older, reported Barbara Cardoso, PhD, of Monash University in Notting Hill, Australia, and co-authors. For each 10% rise in ultraprocessed food consumption, the risk of dementia rose by 0.24 points (95% CI 0.16-0.32, P<0.001) on the modified CAIDE (Cardiovascular Risk Factors, Aging, and Incidence of Dementia) scale, a tool designed to estimate a middle-age person's long-term risk of developing dementia, Cardoso and colleagues said. The relationships persisted even in people who followed a Mediterranean diet, the researchers wrote in Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring. A 10% increase in

Paging Dr. AI; Myth Busting in Cancer; Oncologists Shine in Malpractice Survey

— News, features, and commentary about cancer-related issues May 1, 2026 • 2 min read Could the growing influence of artificial intelligence (AI) in healthcare lead to a license to practice oncology? (ASCO AI in Oncology) Informed by an analysis of 2,000 abdominal CT scans, a next-generation AI system helped clinicians identify pancreatic cancer up to 3 years before clinical diagnosis. (Mayo Clinic) Using serial facial photos of patients with cancer, an AI program showed that signs of accelerated biological aging predicted lower odds for survival. (Mass General Brigham) A phase III trial of light-activated synthetic hypericin for cutaneous T-cell lymphoma ended early after an interim analysis showed the trial was unlikely to meet the primary endpoint, Soligenix announced. Busted: The truth behind seven myths about lung cancer. (CNN) Sara Gore, the 49-year-old host of NBC New York's "Open House" and "New York Live," announced her breast cancer diagnosis. (People) Myths, taboos, and outdated information are addressed in new prostate cancer screening guidelines for patients that also show the benefits of screening outweigh the harms, according to the National Comprehensive Cancer Network. An overlooked measure in the 2022 Inflation Reduction Act may be helping Medicare beneficiaries with adherence to costly

New Therapies for Chronic Spontaneous Urticaria Expand Options Beyond Anti-IgE Care

— Dermatologists can now take more control of treating CSU patients, says Gil Yosipovitch by Gregory Laub, Senior Director, Video, MedPage Today May 1, 2026 • 1 min read Discussions at the American Academy of Dermatology annual meeting highlighted a rapidly evolving treatment landscape for chronic spontaneous urticaria (CSU), with new targeted therapies expanding options beyond traditional antihistamines and anti-immunoglobulin E (IgE) approaches. In this exclusive MedPage Today video, Gil Yosipovitch, MD, of the University of Miami Miller School of Medicine, reflects on the past year of approvals and what they mean for dermatologists taking a more central role in managing CSU. Following is a transcript of his remarks: So big, major advances have occurred in the last year with approval of two drugs that target the neuroimmune system and mast cells. One that we are all familiar [with] as dermatologists because it's been in the market for the last 10 years is dupilumab (Dupixent). It is a biologic injectable targeting the IL [interleukin]-4 receptor and this cascade affects the neuroimmune aspect of chronic urticaria. And second is a drug that targets the mast cell that is an oral medication, remibrutinib (Rhapsido), which is a Bruton's tyrosine kinase [inhibitor]. And

FDA Approves First Non-Antipsychotic Drug for Alzheimer's Agitation

— Oral NMDA receptor antagonist gets an expanded indication by Judy George, Deputy Managing Editor, MedPage Today May 1, 2026 • 2 min read The FDA expanded the indication for dextromethorphan hydrobromide and bupropion hydrochloride (Auvelity) extended-release tablets to treat agitation associated with Alzheimer's disease dementia, the agency announced Thursday. This decision marks the first approved treatment for Alzheimer's dementia that is not an antipsychotic, the FDA said. The drug initially was approved to treat major depressive disorder in 2022. "This approval represents a significant advancement in our ability to help patients and families dealing with one of the most challenging aspects of Alzheimer's disease," said FDA Commissioner Marty Makary, MD, MPH. Agitation is common in people with Alzheimer's dementia and can include excessive motor activity or verbal or physical aggression, affecting patients' and caregivers' quality of life, the agency noted. "For too long, people living with Alzheimer's disease agitation and their families have had limited options, and the options that existed came with significant risks," Joanne Pike, DrPH, president and CEO of the Alzheimer's Association, said in a statement. "This approval gives patients, caregivers, and clinicians an important new tool -- one that works through a different mechanism than

Center Providing Uterus Transplants Reports More Live Births

Beginning in 2016, the Baylor University Medical Center research uterus transplant protocol allowed 20 uterus transplants in consenting women, after which transplantation was offered clinically.As of April at the single center, 33 women with a viable transplanted uterus underwent embryo transfer, resulting in 47 pregnancies among 31 women.Maternal complications occurred in 8 of 27 women, and obstetric complications occurred in 14 of 31 live birth pregnancies. A single-center study continued to show the feasibility of live birth after uterus transplantation among women with absolute uterine infertility. As of April at the Texas medical center pioneering the procedure, 33 women with a viable transplanted uterus underwent embryo transfer, resulting in 47 pregnancies among 31 women, reported Liza Johannesson, MD, PhD, of Baylor University Medical Center in Dallas, and colleagues in a research letter in JAMA. Ultimately, there were 31 live births among 27 women (23 women delivered one child, and four women delivered two children), and there were four pregnancies ongoing. "These data support the feasibility of uterus transplant in specialized, multidisciplinary centers capable of integrating transplant surgery, reproductive medicine, and maternal-fetal care," the authors wrote. Johannesson told MedPage Today that "this study is important because uterus transplantation is rapidly moving

Novel Pulsed Field Ablation System Turns to High-Energy, Ultra-Short Zaps

The future of pulsed field ablation (PFA) technology could go in the direction of high-voltage nanosecond energy bursts, according to early results of a novel device. With CellFX nsPFA-360 PFA for paroxysmal atrial fibrillation (Afib or AF), acute electrical isolation of all pulmonary veins (PVs) was achieved in 100% of cases in a 177-person first-in-human study from a group led by Vivek Reddy, MD, of Mount Sinai Fuster Heart Hospital in New York City. The main safety result was a "reasonable" 1.7% incidence of device- or procedure-related serious adverse events: one each of inflammatory pericardial effusion, hemolysis with acute kidney injury, and stroke. Of note, there were no instances of phrenic nerve palsy, PV stenosis, esophageal complications, or death. The study was presented at the annual Heart Rhythm Society meeting and its manuscript published in JACC: Clinical Electrophysiology. Based on invasive remapping at 2-3 months, PV isolation (PVI) lesion durability reached 91% with 5-second applications with the CellFX system; this was notably better than the 79% durability seen with 2.5-second applications also tested. Additional nanosecond PFA was performed for incomplete lesions at this point. "It is well accepted that achieving durable PVI is essential for enhancing long-term freedom from atrial

Novel ICD Lead for Conduction System Pacing Enters the Arena

A dedicated bipolar implantable cardioverter-defibrillator (ICD) lead for conduction system pacing (CSP) performed well in a first-in-human multicenter study. Placement of the novel UltiSynq CSP ICD lead, designed for left bundle branch area (LBBA) pacing, met expectations for safety and effectiveness in over 200 patients with indications for novo ICD or cardiac resynchronization therapy defibrillator (CRT-D) implantation, according to researchers led by Robert Schaller, DO, of the Hospital of the University of Pennsylvania in Philadelphia. In these patients, the 3-month major complication-free rate was 97.5% and the primary effectiveness endpoint (a composite of acceptable pacing capture threshold and R-wave sensing amplitude) reached 94.6%, both exceeding preset goals (88% and 80%, respectively). Additionally, lead electrical performance remained stable through 3 months, Schaller told the audience at the Heart Rhythm Society annual meeting held in Chicago. These and other findings from the single-arm, pivotal ASCEND CSP investigational device exemption study were simultaneously published in Heart Rhythm. "These findings support the early safety and performance of a purpose built CSP ICD lead and demonstrate that integration of physiologic pacing into ICD systems can be achieved without compromising defibrillation reliability. Continued follow-up is essential to confirm long-term durability, electrical stability, and extractability. If sustained,

FDA Opens Early Access to Novel Pancreatic Cancer Drug Generating Buzz

— Requests for treatment with daraxonrasib must come from licensed U.S. physicians May 1, 2026 • 2 min read The FDA has given the green light to an expanded access program (EAP) for the investigational pancreatic cancer drug daraxonrasib. In a "safe to proceed" letter to Revolution Medicines, the FDA gave its approval to initiate the EAP in collaboration with licensed prescribers. The approval came just 2 days after the FDA received the company's application for an EAP. "Granting the request 2 days after receiving the expanded access application reflects the FDA's strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer," FDA Commissioner Marty Makary, MD, MPH, said in a statement. "Having taken care of many patients with metastatic cancer, I am hopeful that today's action will improve the lives of patients suffering from this disease." The EAP approval for daraxonrasib continues a string of good news that began just 3 weeks ago when the company announced an "unprecedented" improvement in overall survival with the RAS inhibitor in patients with previously treated metastatic pancreatic cancer. Median OS essentially doubled from 6.7 months with standard therapy to 13.2 months with daraxonrasib. A week later

Study Examines if Prenatal Exposure to Sedatives Is Linked to Psych Disorders

Prenatal exposure to benzodiazepines or Z-hypnotics was not associated with an increased risk of psychiatric or neurodevelopmental disorders in children in a South Korean cohort study.An initial link was observed, but it disappeared in a sibling-controlled analysis, suggesting that familial or environmental factors -- rather than medication -- was driving the association.While the findings offer reassurance, the researchers cautioned that this study does not rule out other pregnancy risks, such as miscarriages or congenital malformations. Prenatal exposure to sedative drugs used for anxiety and insomnia was not associated with an increased risk of psychiatric or neurodevelopmental conditions in children when accounting for familial factors, a large population-based cohort study from South Korea indicated. An analysis of 3.8 million children initially suggested that prenatal exposure to benzodiazepines or Z-hypnotics was tied to a higher risk of psychiatric disorders compared with no exposure over a median 6.85-year follow-up, but this association disappeared in a sibling-controlled analysis (HR 0.99, 95% CI 0.94-1.04). This suggested that familial or environmental factors -- rather than the medication itself -- likely drove the initial findings, noted Ju-Young Shin, PhD, of Sungkyunkwan University in Seoul, and colleagues. Furthermore, there were no increased risks for 12 individual disorders, the

Real-Time Trial Review Needs a Response Plan, Not Just a Data Feed

When the FDA announced recently that two drug companies had begun streaming clinical trial data to agency reviewers in real time, FDA Commissioner Marty Makary, MD, MPH, reached for an analogy from his own training. As a surgical oncologist, he watched his patients in the operating room and ICU on continuous monitors. When vitals dropped, the team intervened. Nobody waited for a report in the mail. Why, he asked, should regulatory oversight of experimental drugs be any different? It's a good analogy. It also gives away more than the announcement intends. Real-time data is not the same thing as real-time oversight. A monitor that beeps in an empty hospital hallway is not a clinical safeguard, and a data feed that arrives at FDA without a defined plan for who acts on it, when, and how is not regulatory review. The challenge in continuous monitoring has never been getting the data. It has been deciding what to do about it. The announcement describes, in detail, a system that delivers signals faster. But right now, it says little about what happens when one arrives. That gap is something we should be watching as this initiative evolves. We have spent decades learning what