Tauklarify Approved for Tau PET Imaging in Alzheimer’s Disease
On Aug. 14, 2026, the US Food and Drug Administration (FDA) approved Lantheus Holdings’ Tauklarify™ (florquinitau F 18 injection, MK-6240) as a radiodiagnostic agent indicated for positron emission tomography (PET) of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease, to identify patients with tau neurofibrillary tangle (NFT) pathology, including tangles isolated to the medial temporal lobe. As an F18-labeled tracer, Tauklarify binds aggregated tau to visualize the density and distribution of NFTs on PET, providing information across the cognitive spectrum, including earlier disease stages. Approval was based on two blinded-read studies of more than 500 subjects across three clinical trials, which demonstrated high negative percent agreement (93–99%) and positive percent agreement of 68–88% for detecting tau NFT pathology. The recommended dose is an intravenous (IV) administration of 185 MBq (5 mCi) 90 minutes prior to imaging. The agent carries a limitation of use as its safety and effectiveness have not been established for evaluating non-Alzheimer’s disease tauopathies. Product labeling notes that Tauklarify should be interpreted alongside other diagnostic assessments, including amyloid PET imaging, because scan results alone may not definitively confirm or rule out tau pathology. Here is the prescribing information.
Executive Order Proposes Changes to US Childhood Immunization Recommendations
On Aug. 10, 2026, President Donald Trump signed the “Gold Standard Childhood Vaccine Recommendations” executive order directing the US Department of Health and Human Services (HHS) to revise federal childhood immunization recommendations. The order calls for reducing the number of universally recommended childhood immunizations from 17 to 11, establishing a three-tiered framework consisting of universal recommendations, high-risk population recommendations, and shared clinical decision-making recommendations. The order also directs HHS to investigate the availability of single-antigen vaccine products, beginning with separate measles, mumps, and rubella (MMR) vaccines when available domestically, and recommends administering childhood vaccines during separate healthcare visits when feasible. The administration stated the policy is intended to align US vaccine recommendations with those of other developed nations and increase parental choice. The executive order follows earlier HHS efforts to implement a three-tiered childhood immunization framework. Those changes were subsequently blocked after legal challenges to the process used to modify federal vaccine recommendations, and the current CDC childhood immunization schedule remains in effect pending further action. The order’s directive to administer separate measles, mumps, and rubella vaccines may pose implementation challenges, as single-antigen products are not currently marketed in the United States and were discontinued in favor of the combination MMR vaccine. Published reports indicate that no new scientific evidence was presented in support of the proposed changes, while current CDC recommendations remain based on decades of accumulated safety and effectiveness data.
Recall
Withdrawal of Alyglo Lots
On July 30, 2026, GC Biopharma Corporation initiated a voluntary market withdrawal for three lots of Alyglo® (immune globulin intravenous, human-stwk) 10% Liquid. The withdrawal was initiated as a precautionary measure due to the potential for an increased rate of allergic hypersensitivity reactions associated with specific lots. Hypersensitivity reactions are a known risk with immune globulin products. Alyglo is FDA-approved for replacement therapy in adults with primary humoral immunodeficiency (PI). To read more about the withdrawal notice, see here.
Morphine Sulfate Injection Recalled
On Aug. 4, 2026, Fresenius Kabi initiated a nationwide voluntary recall of one lot of Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL due to a labeling mix-up. MicroVaults labeled as Morphine Sulfate Injection may contain a prefilled syringe of Dilaudid® (hydromorphone HCl) Injection 0.5 mg/0.5 mL. Because hydromorphone is substantially more potent than morphine, administration of the mislabeled product has a reasonable probability of causing serious adverse health consequences, including life-threatening respiratory depression, overdose, and death. Patients at greatest risk include opioid-naïve individuals, pediatric patients, patients with underlying respiratory disease, and those receiving concomitant central nervous system depressants. As of the recall announcement, no adverse events had been reported. Morphine Sulfate Injection is FDA-approved for the management of pain that is severe enough to require an opioid analgesic when alternative treatment options are inadequate. For more information, see here.
Various Baxter Healthcare Products Recalled
On Aug. 7, 2026, Baxter Healthcare Corporation initiated a voluntary recall of selected lots of Myxredlin® (insulin human), Cardene IV® (nicardipine hydrochloride), Nexterone® (amiodarone HCl), and multiple injectable famotidine, clindamycin, dexmedetomidine, vasopressin, vancomycin, pantoprazole, and daptomycin products due to the potential for contamination with a beta-lactam drug product. Products containing beta-lactam compounds may cause allergic reactions, including severe and potentially life-threatening hypersensitivity reactions, in individuals with beta-lactam allergies. For additional information regarding affected products, lot numbers and expiration dates, see the manufacturer’s recall notice here.
FDA Advisory Committee Recommends Several Peptides for Potential Compounding Issues Document Now Available
In July 2026, FDA’s Pharmacy Compounding Advisory Committee (PCAC) reviewed seven peptide-related bulk drug substances for potential inclusion on the Section 503A Bulks List. The review comes amid growing consumer interest in peptide products marketed for wellness, metabolic health, longevity and performance enhancement, many of which lack the level of clinical evidence typically required to support FDA approval. While FDA staff recommended against inclusion of all seven peptides, PCAC recommended six of the seven substances for potential inclusion. This document summarizes the regulatory, clinical, and policy considerations discussed during the July 2026 PCAC meeting and outlines the potential implications for peptide compounding, patient access, and future FDA actions. The document is attached.