The LungFX approval gives United Therapeutics control of a centralized donor lung evaluation platform, although clinical warnings, logistics and economics will influence adoption.
The European approval takes Enhertu beyond organ-specific oncology, although its clinical reach will depend on reliable HER2 testing, reimbursement and safety management.
See how Merck’s IDVYNSO ADAP agreement could widen HIV treatment access while pricing, formularies and clinical limits shape uptake.
See how Natera’s Signatera could sharpen APG-157’s Phase 3 evidence in head and neck cancer and what risks remain. Read the analysis.
AbbVie has secured a broad pediatric label for Skyrizi, adding both plaque psoriasis and active psoriatic arthritis alongside a new dose for children weighing less than 40 kg. The approval could strengthen treatment choice, although the evidence supporting the two indications is not equally direct.
The FDA has delayed NASP without raising clinical approvability concerns, shifting attention to manufacturing controls, contract facilities and Sobi’s resubmission strategy.
Discover what Johnson & Johnson’s new IMAAVY data mean for earlier gMG treatment, sustained control, safety and FcRn competition.
Larimar’s rolling BLA submission and long-term nomlabofusp data strengthen the case for a potential disease-modifying Friedreich’s ataxia therapy.
Discover how Nippon Shinyaku’s EXG-7001 option could advance full-length dystrophin mRNA therapy for Duchenne muscular dystrophy.
Anixa Biosciences has presented completed Phase 1 data for its alpha-lactalbumin breast cancer vaccine and updated survival observations for liraltagene autoleucel in recurrent ovarian cancer. The findings strengthen the biological rationale behind both programmes, but controlled efficacy evidence, biomarker clarity and successful dose optimisation remain essential before either platform can be considered clinically validated.