Pimicotinib Gives Tenosynovial Giant Cell Tumor a Third Oral Drug, and the First Taken Once a Day
The FDA approved pimicotinib on Nov. 10 after a 56 percent week-25 response rate, the third CSF-1R inhibitor for TGCT and the only one dosed daily.
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Clinical
Evidence, guidelines, and the judgment calls that never make it into the guideline.
How Does Oral Orforglipron Compare With Tirzepatide for Obstructive Sleep Apnea?
The CDC's Ebola Entry Ban Reaches Its Eighth Order in 176 Days, Still Limited to Three Countries
FDA Approves Asundexian as the First Factor XIa Inhibitor for Secondary Stroke Prevention
The FDA Adds an Optic Nerve Warning to All 12 GLP-1 Drug Labels and Stops Short of Europe's Advice
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Pelacarsen and Ziltivekimab Hit Their Targets but Not Cardiovascular Events. Six Outcome Trials Are Still Running.
Pelacarsen cut Lp(a) about 78 percent and ziltivekimab cut hs-CRP, yet both hazard ratios sat near 1.0. Our registry count finds six outcome trials left.
Treating the Biological Trigger: The Role of Hormones in Postpartum Psychosis
The case raises a critical question: What if providers are only treating the smoke while ignoring the fire?
FDA Warns About Medline Beds After Two Deaths. The Beds Can Stay in Use Only if They Stay Unplugged.
Medline is exiting the bed market after 2 deaths and 16 serious injuries. FDA's Oct. 29 alert says to unplug its beds between adjustments.
FDA Proposes New Infant Formula Nutrient Limits. The Vitamin D Floor Doubles and the Iodine Minimum Triples.
A proposed rule due Nov. 2 resets iodine, vitamin A, vitamin D and manganese limits in U.S. infant formula. Comments are due March 2, 2027.
FDA Drops the Heart, Breast Cancer and Dementia Boxed Warnings From Three Estradiol Patches. The Endometrial Cancer Warning Stays.
The FDA relabeled Minivelle, Vivelle and Vivelle-Dot on Oct. 30, bringing updated hormone products to nine. The endometrial cancer box still stands.
FDA Grants Accelerated Approval to Voceryq, a DNA Immunotherapy for Adults With Recurrent Respiratory Papillomatosis
Voceryq is the second immunotherapy for adult RRP. In 26 evaluable patients, 27 percent needed no surgery for a year. A confirmatory trial is still ahead.
DEA Puts Centanafadine, the ADHD Drug Sold as Simtriyo, in Schedule III. Here Is What Changes for Prescribers.
A DEA rule effective Oct. 30 makes Otsuka's ADHD drug Schedule III, not Schedule II like other stimulants, so refills are allowed. Comments close Nov. 30.
One Intranasal Dose of Mebufotenin Eased Treatment-Resistant Depression for Eight Weeks in a Phase 2b Trial
In a 193-patient JAMA trial, one 12 mg dose beat a 0.3 mg comparator by 5.3 MADRS points at day 29. Most patients were ready to leave within two hours.
Left Bundle-Branch Area Pacing Cut Heart Failure Events in AV Block. LEAP-Block Puts a Number on It.
In a 482-patient JAMA trial, left bundle-branch area pacing cut the 24-month composite to 2.4 percent, versus 12.5 percent with right ventricular pacing.
From Nov. 3, U.S.-Bound Flyers Must Attest They Have Not Been in the DRC for 21 Days. Keep Taking Travel Histories.
A CDC order amended Oct. 28 makes everyone on U.S.-bound flights, crew included, attest they have not been in the DRC for 21 days. It starts Nov. 3.
Pembrolizumab Alone Beat Chemotherapy First Line in dMMR Endometrial Cancer. A New ADC Extended Survival After It.
Pembrolizumab alone cut progression risk 43 percent over chemotherapy in KEYNOTE-C93; sacituzumab tirumotecan added 6.9 months of survival in TroFuse-005.
Adding Tarlatamab to Durvalumab Maintenance Cut the Risk of Death 58 Percent in Extensive-Stage Small Cell Lung Cancer
Median survival was 21.1 versus 12.7 months in DeLLphi-305. Half of patients had cytokine release syndrome, and the use is not yet approved.
Spacing Immunotherapy to Every 12 Weeks Failed in the MOIO Trial. More Patients Died.
The phase 3 MOIO trial stopped early after deaths reached 19.9 percent with 12-weekly checkpoint inhibitors versus 10.5 percent with standard dosing.
Divarasib Beat Sotorasib and Adagrasib Head to Head in KRAS G12C Lung Cancer. Patients Also Lived Longer.
Divarasib cut the risk of death 44 percent versus sotorasib or adagrasib in the 338-patient Krascendo 1 lung cancer trial. It is not yet approved.
FDA Approves Talazoparib Plus Enzalutamide for HRR-Mutated Metastatic Castration-Sensitive Prostate Cancer
Approved Oct. 26 for castration-sensitive disease, the PARP combination cut the risk of progression or death 52 percent. Survival data are immature.
FDA Approves Once-Weekly Insulin Icodec for Children With Type 2 Diabetes
The FDA announced Oct. 23 that insulin icodec (Awiqli) is now approved for patients 10 and older with type 2 diabetes, the first weekly insulin for children. The pediatric evidence is an 18-patient pharmacokinetic study, and type 1 diabetes remains off the label.
Individualized mRNA Therapy Cut Melanoma Recurrence 42 Percent in Phase 3. The Benefit Started After Six Months.
In INTerpath-001, adding intismeran autogene to adjuvant pembrolizumab lowered the risk of recurrence or death in resected stage IIB-IV melanoma (HR 0.58). Overall survival is immature, and the curves did not separate until after month six.
A Proposed Circadian Subtype of Depression Fit 23 Percent of Patients. They Reported Less Benefit From SSRIs.
In 11,380 adults with depression, those meeting three of six sleep and body-clock criteria had earlier onset, more severe symptoms and poorer self-reported response to SSRIs and SNRIs, a British Journal of Psychiatry study published Oct. 20 found. The data are cross-sectional and self-reported.
FDA Approves Subcutaneous Induction for Risankizumab in Crohn's Disease. The Label's TB Testing Language Also Changed.
Adults with moderately to severely active Crohn's disease can now start risankizumab (Skyrizi) with an at-home on-body injector instead of IV infusion, after AbbVie's Oct. 23 approval. The label now leaves pretreatment tuberculosis testing to clinical judgment across all indications.
A Son's Concussion Led Dr. Frances Meredith to Rethink Recovery
After her son was sent back into a game while concussed, a North Carolina functional medicine physician set out to make head injury care proactive.
FDA Grants Ultomiris Accelerated Approval for IgA Nephropathy. The Approval Rests on Proteinuria, Not Kidney Function.
Ravulizumab is the first C5 complement inhibitor approved for IgAN, based on a 43.4 percent placebo-adjusted drop in proteinuria at week 34. Whether it slows eGFR decline will not be known until the 106-week data.
Moderna and Merck Present Phase 3 Melanoma Data on Oct. 24. Here Is What to Look For in the Numbers.
INTerpath-001 tests the individualized mRNA therapy intismeran autogene plus pembrolizumab in 1,137 patients with resected stage IIB to IV melanoma. The August topline release gave no hazard ratios; full data come at 10:30 a.m. Eastern on Oct. 24.
FDA Approves Bepirovirsen for Chronic Hepatitis B. In Phase 3, 19 Percent Reached Functional Cure Off Treatment.
Hibsago, approved Oct. 20, is the first antisense oligonucleotide for chronic hepatitis B. In the pooled B-Well trials, 233 of 1,220 treated patients reached functional cure versus none on placebo, and the label carries a boxed warning for hepatic flares and thrombocytopenia.
AAD and HS Foundation Issue First Joint Hidradenitis Suppurativa Guidelines. Step Therapy Is Named the Largest Barrier.
The 37 recommendations, published Oct. 20, strongly recommend adalimumab, bimekizumab, infliximab and secukinumab for moderate to severe disease. The academy says evidence does not support insurer step therapy, which delays access to treatment.
FDA Approves the First Generic of Climara Pro, a Once-Weekly Estradiol-Levonorgestrel Patch
The FDA approved Zydus's generic on Oct. 19 for women with an intact uterus, for menopausal vasomotor symptoms and osteoporosis prevention. The agency gave no price or launch date, and the brand label still carries the full boxed warning.
Ending the Universal Hepatitis B Birth Dose Would Raise Chronic Infections by 19 to 83 Percent, a New Model Projects
An Annals of Internal Medicine model of one U.S. birth cohort, published Oct. 20, projects 19 percent more chronic infections by age 20 if the first dose waits until 2 months and 83 percent more under shared decision-making. The federal change it models is on hold in court.
FDA Approves Dostarlimab for MSI-H/dMMR Rectal Cancer. In AZUR-1, 47 Percent Had a Sustained Complete Response Without Surgery.
The Oct. 19 accelerated approval of Jemperli covers stage II or III locally advanced disease and rests on a single-arm trial of 154 patients. Biomarker results on the diagnostic biopsy now decide who is eligible.
Personalized Cardiac Index Targets Did Not Cut Complications After Major Abdominal Surgery. A 90-Day Death Signal Calls for Caution.
In the PELICAN trial of 1,095 high-risk surgical patients, published Oct. 19 in JAMA, the 7-day composite outcome was 44.3 percent with individualized hemodynamic therapy and 46.9 percent with routine care. Deaths by 90 days were higher with the protocol.
FDA Approves Satralizumab for Thyroid Eye Disease. One of Two Phase 3 Trials Missed Its Primary Endpoint.
Enspryng, approved Oct. 15, is the first subcutaneous thyroid eye disease treatment patients can inject at home. In SatraGO-2, 52.9 percent had a proptosis response versus 23.4 percent with placebo; SatraGO-1 missed its endpoint.
Intermittent Dialysis Was Not Noninferior to Continuous Therapy in Critically Ill Patients With AKI. The Trial Stopped Early.
In the 554-patient ICRAKI trial in NEJM, death by day 90 occurred in 63.1 percent of patients started on intermittent hemodialysis and 53.5 percent of those started on continuous therapy. The authors urge caution because the trial stopped early.
Starting Vasopressin Earlier in Septic Shock Did Not Lower 28-Day Mortality. Cardiogenic Shock Was Slightly More Common.
In JAMA's VASSPR trial of 3,959 patients, 28-day mortality was 31.8 percent with a lower vasopressin start threshold and 33.0 percent with a higher one. The confidence interval does not exclude a small difference.
Ebola Outbreak in the DRC Passes 9,300 Confirmed Cases. There Is No Approved Treatment or Vaccine for This Strain.
CDC reports 9,300 confirmed cases and 4,481 confirmed deaths from Bundibugyo virus as of Oct. 14, with no US cases. The approved Ebola antibodies and vaccine do not cover this species, so recognition and isolation matter most.
Pennsylvania's Measles Outbreak Reaches 1,222 Cases and Six Deaths. Here Is the Clinic Checklist.
NBC News reports 225 hospitalizations and a CDC field epidemiologist headed to the state. CDC counts 4,410 US cases this year, nearly double all of 2025, and Pennsylvania still recommends an early MMR dose for infants in outbreak areas.
FDA Approves a Once-Daily Zilbrysq Autoinjector for Generalized Myasthenia Gravis. The Boxed Warning Stays.
UCB's Oct. 16 announcement adds a self-injection device for zilucoplan, with complete dose delivery in 99.8 percent of 449 uses in a 31-patient study. Meningococcal vaccination and REMS enrollment still apply, and launch is expected in early 2027.
CGM Lowered A1c by 0.9 Points More Than Routine Care in Type 2 Diabetes Without Insulin. Coverage Has Not Caught Up.
The Dexcom-funded CONNECT trial of 283 adults, published Oct. 14 in NEJM, ran 26 weeks with little hypoglycemia. Medicare has not yet decided whether to cover sensors for patients not on insulin.
FDA Issues an Early Alert on Edwards' Commander M Delivery System After Balloons Burst. One Death Is Reported.
The Oct. 15 alert names four lots of the system used to deliver the SAPIEN M3 transcatheter mitral valve and cites three reports of balloons bursting during inflation. Facilities are told not to use the lots and to remove them from inventory.
FDA Approves Ryzumvi Eye Drops for Presbyopia. In the Pivotal Trial, About 1 in 4 Patients Reached the Near-Vision Goal.
The Oct. 16 approval adds adults with presbyopia to the label of phentolamine ophthalmic solution 0.75%. In the VEGA-3 trial, 27.2% of treated patients reached the primary near-vision endpoint, against 11.5% on placebo.
FDA Approves Brytly, the First Nonprescription Apraclonidine Eye Drop, for Eye Redness
The Oct. 16 approval covers apraclonidine 0.125% for adults and children 12 and older, at most twice a day. The FDA did not describe the trial data, and the Drug Facts label was not yet posted, so the stop-use rules are what clinicians can act on now.
AASLD Issues Its First Expert Opinion Document, and It Is on Liver Biopsy. It Is Not a Guideline.
The society's first Expert Practice Opinion updates its 2009 biopsy guidance, adds endoscopic ultrasound-guided biopsy and sets specimens of more than 1.5 cm. It rests on expert consensus, not GRADE, and sets no INR or platelet cutoff.
Par Health Recalls 22 Lots of Argatroban Injection for Particulate Matter. Ask Pharmacy Which Lots You Have.
The Oct. 13 recall covers argatroban 250 mg/2.5 mL vials shipped nationwide from Dec. 30, 2024, to May 5, 2026. Par reports no adverse events so far but warns of a risk of pulmonary emboli.
Inhaled Isoflurane Sedation Did Not Lower Mortality in Hypoxemic Respiratory Failure. SAVE-ICU Found More Adverse Events.
In the 780-patient SAVE-ICU trial, published in JAMA on Oct. 14, hospital mortality was 42.5 percent with an isoflurane-based strategy and 43.8 percent with intravenous sedation. All five serious adverse events occurred in the inhaled arm.
Dr. David Borenstein on the FDA Erasing Hormone Therapy's Black Box Warning, and Why Men's Hormone Levels Are Getting More Attention Too
In February the FDA removed cardiovascular, breast cancer and probable dementia language from the boxed warning on six menopausal hormone therapy products. Testosterone prescribing in men has rebounded past its 2013 peak. Dr. David Borenstein says both point to the same shift.
Adding Dobutamine During Source-Control Surgery Cut Kidney Injury in Septic Shock. Mortality Did Not Differ Significantly.
In a 584-patient JAMA trial from 39 Chinese hospitals, published Oct. 14, new or worsening acute kidney injury within 7 days fell from 34.7 percent to 22.8 percent when intraoperative dobutamine was added to norepinephrine. Tachycardia was more common.
Flu Is Rising Early on the West Coast, and Nearly All Subtyped Viruses Are H1N1. Check Your Antiviral and Vaccination Plans Now.
CDC's latest FluView, for the week ending Oct. 3, shows 3.6 percent of lab specimens positive and 3,334 flu admissions, with the highest activity on the West Coast. Outpatient illness is still below baseline.
FDA Will Let Salt Substitutes Into Standardized Foods From Dec. 14. Patients Who Limit Potassium Should Read Labels.
A final rule published Oct. 13 lets manufacturers replace some or all added salt in foods such as canned vegetables, canned tuna and cheeses. FDA does not name the substitutes, but potassium chloride is the familiar one.
FDA Expands Anktiva to Papillary-Only BCG-Unresponsive Bladder Cancer. The Evidence Comes From CIS Patients.
On Oct. 14 the FDA extended nogapendekin alfa inbakicept-pmln, given with BCG, to high-grade papillary-only non-muscle invasive bladder cancer. The response figures behind it come from a single-arm trial in carcinoma in situ.
Nicotinamide Riboside Did Not Slow Early Parkinson Disease in a 410-Patient JAMA Trial. Scores Were Slightly Worse.
In the 52-week NOPARK trial at 11 Norwegian centers, MDS-UPDRS parts I to III rose 2.72 points more with the over-the-counter supplement than with placebo (P = .02). It is the evidence to cite when patients ask about NAD boosters.
Two ESR1 Approvals in Two Weeks Set Two Different Testing Schedules. The Evidence Behind Each Is Not the Same.
The FDA approved camizestrant on Sept. 4 for ESR1 mutations found on circulating tumor DNA before progression, and imlunestrant with abemaciclib on Sept. 18 for ESR1-mutated disease after progression. The evidence differs, and so does when the test is ordered.
FDA Approves Once-Monthly Subcutaneous Olanzapine (Weltruza) for Schizophrenia
Teva said Oct. 9 that FDA approved Weltruza, a once-monthly subcutaneous olanzapine for adults with schizophrenia, with no post-injection monitoring required. All three doses beat placebo at week 8 in SOLARIS, but whether PDSS can occur with it is not known.
FDA Advisers Meet Oct. 30 on Low-Dose Atropine for Childhood Myopia. The Agency Declined to Approve It Last Year.
An FDA advisory committee meets Oct. 30 on Sydnexis's atropine 0.01% to slow myopia progression in children 3 and older, a year after a complete response letter. Requests to speak are due Oct. 14 and written comments by Oct. 19.
FDA Approves Lirafugratinib for Previously Treated FGFR2-Rearranged Cholangiocarcinoma. The Evidence Is a Single-Arm Trial.
The FDA approved lirafugratinib (Lyrfigtu) on Sept. 23 for previously treated cholangiocarcinoma with an FGFR2 fusion or rearrangement, based on a 116-patient single-arm trial with a 46 percent response rate. No FDA-authorized test exists, so testing is the first step.
FDA Adds a Boxed Warning to Injectafer for Low Phosphate Levels. Check How Your Infusion Protocols Handle It.
FDA's Sept. 1 Drug Safety Communication says serum phosphate was measured in fewer than 20 percent of ferric carboxymaltose administration episodes. The new boxed warning calls for a check before any repeat course within three months.
FDA Approves Mavacamten for Children With Symptomatic Obstructive HCM. The Label Starts at 30 Kilograms.
The Food and Drug Administration approved mavacamten (Camzyos) on Sept. 30 for children with symptomatic obstructive hypertrophic cardiomyopathy who weigh at least 30 kg. The evidence is 44 adolescents and a gradient endpoint, and the boxed warning and REMS apply.
FDA Approves Atezolizumab With Chemotherapy as Adjuvant Therapy for Stage III dMMR Colon Cancer
The Food and Drug Administration approved atezolizumab with a fluoropyrimidine and oxaliplatin on Oct. 8 for resected stage III dMMR colon cancer. In ATOMIC, the disease-free survival hazard ratio was 0.50, but overall survival data are still immature.
FDA Approves Belzutifan Plus Lenvatinib for Advanced Clear Cell Kidney Cancer After a PD-1 Inhibitor. Overall Survival Did Not Reach Significance.
The Food and Drug Administration approved belzutifan with lenvatinib on Sept. 24 for clear cell RCC after PD-1 or PD-L1 therapy. In LITESPARK-011, median progression-free survival was 14.6 vs 10.6 months against cabozantinib, but final overall survival was not statistically significant.
FDA Approves Pritelivir for Acyclovir-Refractory HSV in Immunocompromised Adults. Here Is What the Label Covers.
The FDA approved oral pritelivir (Hovilpri) on Oct. 9 for immunocompromised adults with mucocutaneous HSV lesions refractory to acyclovir-class drugs. In the open-label phase 3 PRIOH-1 trial, 63 percent healed by day 28 versus 34 percent on investigator's choice.
FDA Holds a Webinar Oct. 14 on Its Bayesian Trial Guidance. Here Is How to Read the Trials It Covers.
The Center for Drug Evaluation and Research holds a one-hour webinar Oct. 14 on its January draft guidance for Bayesian trials. The guidance is nonbinding, but it sets out how to weigh a prior, a posterior probability and borrowed data.
FDA Approves Tucatinib as First-Line Maintenance for HER2-Positive Metastatic Breast Cancer
The oral HER2 inhibitor, added to trastuzumab and pertuzumab after induction, extended median progression-free survival by 8.6 months in HER2CLIMB-05. The label carries a boxed warning for hepatotoxicity.
FDA Approves Remibrutinib for Symptomatic Dermographism Not Controlled by Antihistamines
The oral BTK inhibitor, already approved for chronic spontaneous urticaria, now covers adults whose friction-triggered hives are not controlled by H1 antihistamines.
Pirtobrutinib Moves to First Line in CLL. Here Is What the Approval Covers.
The FDA has approved the non-covalent BTK inhibitor for adults with previously untreated CLL or SLL without a known 17p deletion. The data come from a trial against chemoimmunotherapy, and the label carries warnings on infections, bleeding and heart rhythm.
Tavapadon Brings a New Kind of Dopamine Agonist to Parkinson's Care
The FDA has approved AbbVie's once-daily tavapadon, sold as Juvmo, the first selective D1/D5 receptor agonist for Parkinson's disease. Here is what the TEMPO trials showed and what the label warns about.
Why Physicians Ignore Sepsis Alerts, and How to Build Ones They Trust
Alert fatigue is a design flaw, not a discipline problem. The best early warning systems earn attention by being right when they speak.
Diagnostic Error and the Case for the Second Look
Most diagnostic mistakes are not exotic diseases missed. They are common conditions seen through the wrong frame.
The Deprescribing Conversation Most Patients Are Waiting For
Stopping a medication is often harder than starting one. A simple framework for older adults on too many drugs.
Who Owns the Test Result That Comes Back After Discharge?
Results that return after a patient leaves are one of the quietest gaps in medicine. Closing it takes named ownership, a simple tracking habit, and a clear patient script.
The Handoff Is a Clinical Act, Not a Clerical Chore
Sign-out is where diagnostic reasoning either travels with the patient or quietly disappears. A few disciplined habits make handoffs carry thinking, not just a list of tasks.
Why Low-Value Testing Outlasts Every Campaign Against It
Physicians generally know which tests rarely help. They order them anyway, for reasons that have more to do with defaults, habits, and fear than with knowledge.
How to Make Shared Decision Making More Than a Checkbox
Shared decision making is often documented and rarely practiced. A simple structure helps physicians offer real choices without turning every visit into a seminar.
Reading a Guideline Like a Clinician, Not a Compliance Officer
Clinical practice guidelines are indispensable and imperfect. Knowing how to weigh their strength, scope, and fit for the patient in front of you is a core clinical skill.
What to Do With the Incidental Finding Nobody Was Looking For
Imaging reveals more than anyone asked for. How physicians communicate, track, and decide on incidental findings shapes patient anxiety, safety, and the downstream cost of care.
The Art of Telling a Patient You Are Not Sure Yet
Many visits end without a firm diagnosis. Communicating uncertainty honestly, and giving patients clear return instructions, is one of the most protective things a physician can do.
How to Talk About Risk in Numbers Patients Can Actually Use
Relative risk, percentages, and vague adjectives leave patients guessing. A few simple habits turn probability into something a patient can weigh against their own life.
Across The Script Pad
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What the AMA's House of Delegates Decided in Orlando, From AI Licensure to Downcoded Claims
By our count the AMA adopted 15 policies at its Nov. 6-9 meeting, including a bar on licensing AI as a physician and EHR alerts for downcoded claims.
Seventeen Physician Specialties Are Now Severe Shortages at One in Five VA Facilities or More
The VA inspector general's 2026 survey found severe physician shortages at 135 of 139 facilities, with radiology, urology and anesthesiology rising most.
Year Two of the Rural Health Fund Shifts $68 Million Among States, Less Than 1 Percent of the Total
CMS awarded $10 billion in Year 2 rural health funds on Nov. 9. Against Year 1, 25 states gained and 25 lost; North Dakota and Florida moved most.
This Year's 5,182 Measles Cases Exceed 2018 Through 2025 Combined. The Elimination Review Is Due This Month.
CDC counts 5,182 U.S. measles cases in 2026, 711 more than the prior eight years combined, as PAHO weighs whether the U.S. keeps elimination status.