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596 articles, sorted by publication time.
A recent U.S. FDA draft guidance has drawn industry attention; rather than simply easing repeated testing, the next focus is whether developers can clearly demonstrate sufficient relevance between public information, platform experience, and their own products.
daraxonrasib showed an approximately doubled median survival in previously treated metastatic pancreatic cancer, bringing RAS-targeted therapy back to the center of clinical discussion; however, before formal approval, the magnitude of benefit, safety profile, and eligible population still need to be defined through regulatory review.
Phase 1 data presented at ASCO show that Greywolf Therapeutics’ GRWD5769, combined with cemiplimab, was associated with tumor shrinkage across multiple advanced cancers that had previously failed immunotherapy; however, the study remains early, and it is not yet possible to determine whether the approach can extend survival or become routine treatment.
The international OPTIMA trial shows that the Prosigna 50-gene test can help determine whether patients with hormone receptor-positive breast cancer need chemotherapy; for low-risk patients treated mainly with hormone therapy, five-year recurrence-free survival results were similar to those of patients who received chemotherapy.
The U.S. FDA approved Amphastar’s 4 mg naloxone hydrochloride nasal spray Rextovy for nonprescription sale for the emergency reversal of suspected opioid overdose. The new product joins the existing OTC naloxone market, while its actual impact on price, supply, and accessibility remains to be seen.
Some U.S. clinics are selling costly umbilical cord stem cell infusion services to families of children with autism, but the related products have not been approved and evidence of efficacy remains limited; the case highlights the gap between commercialization of regenerative medicine and regulation of cell therapies.
The U.S. FDA has released a draft guidance that would allow cell and gene therapy developers, in certain circumstances, to rely more on existing scientific knowledge to reduce unnecessary repeat testing; however, the draft has not yet been finalized, and its actual impact will depend on review standards and implementation details.
GSK has agreed to acquire U.S. cancer drug company Nuvalent for $10.6 billion, gaining two late-stage non-small cell lung cancer drug candidates. The deal shows that major pharmaceutical companies are accelerating efforts to strengthen their oncology portfolios, but the drugs still await regulatory review, and their clinical and commercial prospects have not yet been settled.
After Otarmeni became the first approved gene therapy for OTOF-related hereditary hearing loss, the focus has shifted to clinical implementation: which patients can benefit, how mutation types should be confirmed, and whether early hearing improvements can be maintained over a longer period.
The FDA has cleared Dexcom’s Stelo Glucose Biosensor System for expanded over-the-counter use by people aged 2 and older who are not using insulin, bringing children into the scope of OTC continuous glucose monitoring in the United States for the first time; however, the device is not suitable for all people with diabetes, and clinical interpretation and follow-up care still require caution.
The 30-person trial will assess whether POLB 001 can prevent cytokine release syndrome, which is common during treatment with the bispecific antibody teclistamab; if results are positive, it could change monitoring models for some blood cancer immunotherapies, but it remains early-stage clinical validation for now.
The U.S. FDA has approved teplizumab for children and adolescents aged 8 to 17 with recently diagnosed stage 3 type 1 diabetes to delay the decline in insulin secretion capacity; the decision is an accelerated approval, and clinical benefit still needs to be verified in postmarketing studies.