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.
Recently covered in Neurology Live, investigators have published phase 3b STRENGTH trial data supporting Novartis’ newly approved Itvisma, a one-time intrathecal gene transfer therapy for spinal muscular atrophy (SMA). The 52-week, open-label study enrolled 27 patients aged 2 to 18 years who transitioned from nusinersen or risdiplam to intrathecal onasemnogene abeparvovec and demonstrated a safety profile consistent with prior studies in treatment-naïve patients, with common adverse events including nasopharyngitis, pyrexia, and vomiting. While all participants experienced at least one adverse event, those of special interest, such as transient thrombocytopenia, hepatotoxicity, and possible dorsal root ganglia toxicity, were generally mild to moderate and resolved. Modest motor function improvements were observed at week 52, with most patients maintaining baseline milestones and a subset achieving new gains, supporting Itvisma’s approval alongside data from the pivotal STEER trial and highlighting its role as an additional treatment option for patients transitioning from existing SMA therapies.
As reported by Medical Economics, Nephrodite Inc. has received FDA Breakthrough Device Designation for Holly, its implantable continuous dialysis system designed to provide a transformative alternative to traditional hemodialysis and peritoneal dialysis for patients with end-stage kidney disease. Supported by encouraging multi-day large animal data, Holly is intended to function as a continuously operating internal implant that more closely mimics natural kidney physiology, integrating advanced hemofiltration, biocompatible materials, intelligent sensors, machine learning, and remote monitoring while reducing reliance on frequent clinic visits. Company leaders emphasized that the designation enables closer collaboration with regulators and accelerates progress toward first-in-human trials, positioning Holly as part of a broader wave of innovation aimed at improving quality of life, personalization, and physiologic stability in kidney replacement therapy.
As reported by CURE, the FDA has approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), the first and only subcutaneous therapy for patients with EGFR-mutated non–small cell lung cancer across all indications, offering a faster, chemotherapy-free option that reduces administration time from hours to minutes and significantly lowers infusion-related reactions compared with intravenous delivery. The approval was supported by phase 3 PALOMA-3 data showing that the subcutaneous formulation met pharmacokinetic end points and was associated with improved progression-free and overall survival versus IV Rybrevant, with 65% of patients alive at 12 months compared with 51% in the IV group, as well as fewer infusion reactions and lower rates of venous thromboembolism. Building on survival benefits previously demonstrated in the MARIPOSA study, Rybrevant Faspro provides a more patient-centered treatment experience while maintaining efficacy and a safety profile consistent with intravenous administration.
As reported by Pharmacy Times, 2025 brought several notable FDA updates affecting medication therapy management, including the launch of at-home FluMist nasal influenza vaccination, expanded MTM trends seen in community practice, opioid labeling changes, and new drug approvals. FluMist became available for home delivery in August 2025 for eligible patients aged 2 to 49 years, while pharmacists reported increased use of SMART therapy with budesonide/formoterol, greater prescribing of propranolol for anxiety, hormone therapies across sexes, and oral minoxidil for hair loss. Regulatory changes included removal of the clozapine REMS program to improve access, updated opioid safety labeling to address long-term risk, and approval of gepotidacin (Blujepa), the first novel oral antibiotic class for uncomplicated UTIs in nearly 30 years, highlighting pharmacists’ expanding role in patient education and medication safety.
Reported by Urology Times, the FDA granted regular approval to rucaparib (Rubraca) for adults with BRCA mutation–associated metastatic castration-resistant prostate cancer who have progressed on prior androgen receptor–directed therapy, converting its May 2020 accelerated approval to full approval. The decision was supported by the phase 3 TRITON3 trial, in which rucaparib significantly improved radiographic progression-free survival compared with physician’s choice of therapy in patients with BRCAm tumors (median rPFS, 11.2 vs 6.4 months), with benefit largely driven by the BRCA-mutated population rather than those with ATM mutations. The FDA recommends selecting patients using an approved companion diagnostic and dosing rucaparib at 600 mg orally twice daily until disease progression or unacceptable toxicity.
Want to read more on specialty care, pharmacy, industry sciences, and more? Check out MJH Life Sciences full list of brands here.
