The Rx Recap: October 12-17

Welcome to this week’s roundup of the most insightful and impactful articles from the sister publications of Dermatology Times, all under One MJH Life Sciences. Our network brings together expert perspectives, clinical advancements, and industry updates to keep clinicians informed and ahead of the curve. From cutting-edge treatments to practice management strategies, here’s a look at the top stories shaping the field of medicine.

FDA Approves Expanded Indications for Adalimumab-Aaty for Pediatric Indications

As reported by Drug Topics, the FDA has expanded the approval of adalimumab-aaty (Yuflyma; Celltrion) and its unbranded biosimilar to include treatment of hidradenitis suppurativa (HS) in patients 12 years and older and uveitis (UV) in patients 2 years and older, extending access to younger populations affected by these chronic inflammatory conditions. Developed by Celltrion USA, Yuflyma—a biosimilar to adalimumab (Humira)—was already approved for several autoimmune diseases and recently gained expanded interchangeability designation for its prefilled syringes and autoinjectors. Company leaders noted that the update reflects Celltrion’s commitment to improving treatment accessibility and addressing unmet needs in both adult and pediatric immune-mediated diseases.

FDA accepts Afrezza sBLA for pediatric diabetes

As reported by Contemporary Pediatrics, the FDA has accepted MannKind Corporation’s supplemental biologics license application (sBLA) to expand Afrezza (insulin human) Inhalation Powder for use in children and adolescents with type 1 or type 2 diabetes, with a PDUFA target action date of May 29, 2026. If approved, Afrezza would become the first rapid-acting inhaled insulin available to pediatric patients, offering an alternative to multiple daily injections or insulin pumps. The application is supported by results from the phase 3 INHALE-1 trial, which demonstrated the safety and efficacy of Afrezza in patients aged 4 to 17 years. MannKind leaders said the expansion could fill an important gap in pediatric diabetes care by providing a less invasive insulin delivery option.

Novel therapy for managing canine OA pain gains momentum in global markets

As reported by dvm360, the FDA has accepted MannKind Corporation’s supplemental biologics license application (sBLA) to expand the indication of Afrezza (insulin human) Inhalation Powder for pediatric patients with type 1 or type 2 diabetes, setting a PDUFA target action date of May 29, 2026. If approved, Afrezza would be the first rapid-acting inhaled insulin for children and adolescents, offering an alternative to injections or insulin pumps. The submission is backed by data from the phase 3 INHALE-1 trial, which evaluated Afrezza’s efficacy and safety in patients aged 4 to 17 years. MannKind officials emphasized that the potential approval represents a major step toward expanding insulin delivery options and improving treatment accessibility for younger patients living with diabetes.

FDA Grants FTD to Novel Cancer Vaccine in Low Tumor Burden Follicular Lymphoma

As reported by Cancer Network, the FDA has granted fast track designation to EO2463, an off-the-shelf OncoMimics active immunotherapy vaccine developed by Enterome, for patients with follicular lymphoma in the low tumor burden “watch-and-wait” setting. The designation follows promising results from the phase 1/2 SIDNEY trial (NCT04669171), in which EO2463 monotherapy achieved an objective response rate of 46%, including 15% complete responses, among newly diagnosed patients. EO2463 combines synthetic bacterial peptide antigens that mimic key B-cell lineage markers (CD20, CD22, CD37, and CD268) to stimulate targeted immune responses. The therapy demonstrated a favorable safety profile, with mostly mild local reactions and no unexpected toxicities. According to Enterome CEO Pierre Belichard, the FDA’s decision validates the OncoMimics platform and paves the way for registrational testing of EO2463 as early as next year.

Samsung completes acquisition of digital health platform Xealth

As reported by Medical Economics, Samsung Electronics Co. Ltd. has finalized its acquisition of Xealth, a leading digital health platform that connects patients and providers through digital tools and care programs. The merger combines Samsung’s wearable technology ecosystem with Xealth’s data integration capabilities to advance a more connected and preventative approach to healthcare. By linking real-time health data from Samsung devices directly to clinical systems, the partnership aims to improve preventative care, chronic disease management, and clinical decision-making. Xealth’s platform already integrates digital health solutions across more than 500 US hospitals and 70 partner companies, including Advocate Health and Banner Health. Under Samsung, Xealth will retain its brand and leadership while helping expand access to personalized digital health solutions worldwide.

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