Author: Frank Jost

The Food and Drug Administration approved Juvmo (tavapadon) on September 28, 2026, clearing AbbVie’s once-daily pill as the first drug in a new pharmacological class for Parkinson’s disease: a selective agonist of the D1 and D5 dopamine receptors, rather than the D2/D3 receptors targeted by existing dopamine agonists such as pramipexole and ropinirole. AbbVie says the drug will reach U.S. pharmacies in October 2026. Tavapadon is approved for adults with Parkinson’s disease, taken once a day either on its own in early-stage disease or alongside levodopa, the decades-old drug that remains the backbone of Parkinson’s treatment but that loses effectiveness…

The Food and Drug Administration approved Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin from Eli Lilly, for adults with type 2 diabetes, the agency said in an announcement dated September 24, 2026. According to the FDA, it is only the second once-weekly insulin ever approved for type 2 diabetes in the United States — a small but real shift in a drug class that has been built around daily injections for a century. Onswik is a long-acting insulin analog meant to be injected under the skin once a week, on the same day each week, alongside diet and exercise,…

The Department of Health and Human Services (HHS) published a request for information on September 24, 2026, asking how deceased-donor islet cells for type 1 diabetes (T1D) should be regulated. The notice, issued jointly by the Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA), sets no rule. It opens a public docket, with comments due November 9, 2026, and floats an unusual idea: treating unmodified donor islet cells as organs rather than as biological products. What the notice covers T1D is a chronic autoimmune disease in which the immune system destroys the insulin-producing beta cells…

The Centers for Medicare & Medicaid Services (CMS) published a request for information on September 24, 2026, asking pharmacies, insurers, pharmacy benefit managers (PBMs) and the public how Medicare Part D should define “reasonable and relevant” contract terms for pharmacies. Comments are due November 23, 2026. The notice does not change any rule today; it starts the fact-finding for standards that would apply from 2029. What the notice is, and where it comes from Part D, Medicare’s outpatient prescription drug benefit, is run by private plan sponsors: standalone prescription drug plans (PDPs) and Medicare Advantage plans that include drug coverage…

An FDA advisory panel voted on September 23, 2026, in favor of approving Galleri, a blood test from GRAIL, Inc. that looks for signals of many cancers at once. The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted 7 to 2, with one abstention, that the test’s benefits outweigh its risks. The vote is a recommendation only: the FDA is not bound by it and has not yet issued a final decision on the premarket approval (PMA) application GRAIL filed on January 29, 2026. What Galleri is and who it is for According to the FDA’s…

The Centers for Medicare & Medicaid Services (CMS) has paused registration of new insurance agents and brokers on the federal health insurance marketplace, effective September 22, 2026, and will keep the pause in place until February 1, 2027 unless it is lifted, extended or modified sooner. The measure, published in the Federal Register on September 23 as an interim final rule with comment period, targets a problem the agency describes as unauthorized enrollments and plan switches by commission-paid brokers. What the rule does The rule adds a new provision, 45 CFR 155.220(o), that gives the Department of Health and Human…

The Food and Drug Administration on September 21, 2026, issued a rule that strikes the word “animal” from large parts of its drug-safety regulations, replacing “animal test” and “animal study” with a new umbrella term, “nonclinical test” and “nonclinical study.” The change touches five sections of the federal drug code and formally opens the door to lab-grown organ chips, computer models and cell-based assays as accepted ways to show a drug is safe enough to try in people — but it does not require anyone to use them, and it does not ban animal studies. What the Rule Actually Does…

The U.S. Department of Health and Human Services (HHS) has opened a public request for information on radiofrequency and wireless radiation exposure and human health. The notice, signed by Secretary Robert F. Kennedy, Jr. and published in the Federal Register on September 21, 2026, asks researchers, clinicians, industry and members of the public to submit evidence and experiences by October 21, 2026. It is a call for input, not a rule, a warning or a finding. What the notice does show is which questions the department wants answered, and how it frames them. What HHS is asking for The notice…

On September 18, 2026, the White House and the Centers for Medicare & Medicaid Services (CMS) announced that Medicaid programs in all 50 states, the District of Columbia and Puerto Rico have applied to join GENEROUS, a federal payment model meant to bring Medicaid’s net prescription drug prices in line with what certain other countries pay. According to CMS, 40 states and Puerto Rico have already signed participation agreements. The remaining states have until September 30, 2026 to finalize their applications. What GENEROUS is GENEROUS stands for GENErating cost Reductions fOr U.S. Medicaid. It is a model run by the…

The Food and Drug Administration approved Fayuvi on September 17, the first therapy cleared to treat the underlying cause of Sanfilippo syndrome type A. Here is what the approval package actually shows — including the parts that warrant caution. For families whose children have mucopolysaccharidosis type IIIA (MPS IIIA), better known as Sanfilippo syndrome type A, there has never been an approved treatment that changes the course of the disease. Care has meant managing symptoms while watching a child who developed normally lose language, cognition and motor skills. That changed on September 17, when the FDA approved Fayuvi (rebisufligene etisparvovec-hopf),…