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This article analyzes FDA-approved surgical AI devices, highlighting trends in technology, evidence quality, regulatory pathways, and implications for clinical adoption.
This article critically examines the FDA’s approval of gepirone ER for major depressive disorder despite multiple negative trials, highlighting regulatory flexibility, statistical and clinical considerations, and implications for tran
This article examines disparities in access to corneal cross-linking (CXL) for keratoconus patients in the US, highlighting challenges posed by high costs, insurance limitations, and the transition from Photrexa® to Epioxa™.
The FDA has approved linaclotide (Linzess) for treating irritable bowel syndrome with constipation (IBS-C) in children 7 and older, marking the first official treatment option for pediatric IBS-C.
The FDA has rejected Sydnexis’s low-dose atropine eye drop SYD-101 for controlling childhood myopia progression despite promising trial results, highlighting challenges in demonstrating long-term efficacy and clinical significance in
The FDA has approved Roche’s obinutuzumab for active lupus nephritis in adults, offering a twice-yearly dosing regimen that achieved nearly 50% complete renal remission in trials, marking a significant advancement in lupus nephritis managem
A comprehensive analysis of 903 FDA-approved AI medical devices reveals limited clinical performance data and demographic inclusivity, underscoring the need for ongoing evaluation to ensure safe, effective clinical application.
Trastuzumab deruxtecan (T-DXd) gains FDA approval for HR-positive, HER2-low and HER2-ultralow unresectable or metastatic breast cancer after endocrine therapy progression, offering significant progression-free survival benefits over chemoth
The FDA has approved a subcutaneous form of lecanemab for maintenance therapy in early Alzheimer’s, offering similar clinical benefits to IV dosing with improved convenience and safety, potentially transforming patient care delivery.
The FDA has authorized updated COVID-19 vaccines from Pfizer and Moderna designed to target the LP.8.1 sublineage, expanding vaccination to adults over 65 and individuals with high-risk conditions, enhancing immune defense against evolving
ArteraAI Prostate, the first FDA-approved AI-driven multimodal software, offers personalized clinical decision support for localized prostate cancer, improving treatment precision and reducing overtreatment risks.
The FDA has approved Tonmya (sublingual cyclobenzaprine) as the first new fibromyalgia therapy in 15 years, targeting nonrestorative sleep to alleviate pain, fatigue, and cognitive symptoms in adults.
Alcon introduces Tryptyr, the first TRPM8 agonist eye drop, promising rapid tear production for dry eye disease. FDA-approved in May 2024 following robust phase 3 trials.
The FDA has approved Vizz, a once-daily aceclidine ophthalmic solution, for presbyopia in adults based on robust phase 3 data. The eye drop offers up to 10 hours of improved near vision with a favorable safety profile.
Skytrofa, a once-weekly injectable growth hormone, is FDA-approved for adult GHD, offering improved adherence and positive metabolic outcomes. Clinical trials show superior efficacy and favorable safety compared to daily somatropin.
Lenacapavir (Yeztugo) becomes the first FDA-approved, twice-yearly injectable PrEP, offering robust long-acting HIV prevention and addressing key adherence barriers.
The FDA has approved Sephience, an oral therapy for phenylketonuria (PKU), offering a novel treatment option for both children and adults with this rare metabolic disorder.
Once-weekly lonapegsomatropin (Skytrofa) is now FDA-approved for adult growth hormone deficiency, offering a more convenient alternative to daily injections with demonstrated efficacy and safety.
