Archive
596 articles, sorted by publication time.
The FDA has allowed bemotrizinol for use in U.S. over-the-counter sunscreen products, giving U.S. sunscreen formulations an additional UV filter option covering both UVA and UVB; this rare update also highlights the public health and product design gaps left after years of stagnation in sunscreen ingredient regulation.
The research team presented at the European Society of Human Genetics conference. Using brain organoids built from cells of patients with DHDDS-related disease, they observed possible disease mechanisms and indicated that nicotinamide mononucleotide may have a chance to slow the disease course; however, this remains early-stage research, and efficacy and safety still need confirmation in clinical trials.
The South San Francisco startup is advancing a gene delivery platform centered on ultrasound and microbubbles, aiming to deliver the full-length dystrophin gene into muscle cells without using AAV viral vectors; however, publicly available information remains limited, and efficacy, safety, and clinical feasibility still need to be verified.
Lilly has acquired Texas neuroscience startup 4E Therapeutics, adding oral MNK inhibitors to its pain R&D pipeline; financial terms were not disclosed, and clinical value still needs to be validated in subsequent human trials.
Sacituzumab tirumotecan met the primary endpoints of both overall survival and progression-free survival in the Phase 3 TroFuse-005 trial; however, full data have not yet been released, and its clinical significance still awaits confirmation at a medical meeting and through regulatory review.
The U.S. FDA has completed a final order adding bemotrizinol as an active ingredient that may be used in over-the-counter sunscreen products; this is the first new OTC sunscreen active ingredient in the United States since the late 1990s and could affect future sunscreen product formulations and market competition.
A randomized study of more than 140,000 people in the UK showed that adding the Galleri multi-cancer early detection blood test to standard cancer screening failed to significantly reduce late-stage cancer diagnoses; the results are a reminder that moving blood screening from a technical signal to a population-level public health tool still requires more rigorous evidence.
Replimune and the U.S. FDA have reached agreement on a resubmission pathway for the RP1 biologics license application, giving the oncolytic immunotherapy, which had previously been set back by concerns over evidence and trial design, a new regulatory opportunity; whether this can translate into approval, however, will still depend on the FDA’s final judgment on the strength of the clinical data.
After phase 2 data showed signals of weight loss and improved blood glucose, AstraZeneca said it will advance the once-daily oral GLP-1 candidate elecoglipron into phase 3 development; larger trials are still needed to confirm long-term efficacy, safety, and its actual clinical positioning.
A Dutch team reported in the New England Journal of Medicine that clinical long-read genome sequencing increased the diagnostic rate in a comparison involving 1,000 patients and may integrate multiple current tests; however, costs, interpretation capacity, and implementation outcomes across different healthcare systems still require further evaluation.
AstraZeneca’s experimental oral GLP-1 drug elecoglipron showed early effects on weight loss and A1C improvement in Phase 2 trials, placing it in the highly competitive race for oral obesity and diabetes drugs; however, the data remain mid-stage clinical results, and the durability of efficacy, safety, and whether it can pass late-stage trials still need to be confirmed.
Phase 3 survival data presented at ASCO and the FDA’s expanded access arrangement have made daraxonrasib a focus in second-line treatment for metastatic pancreatic cancer; the truly critical next step is whether these results can undergo full review and be translated into clear, executable clinical standards.