Eli Lilly obesity drug retatrutide wins late-stage trials, FDA approval sought for 2027
Lilly's next-generation GLP-1 receptor agonist shows weight loss efficacy but data leave questions about cardiovascular benefits; company will seek FDA approval
BioPharma Dive · +14 outlets
GSK gains first lung cancer approval for Jideytro following $10.6B Nuvalent acquisition
GSK received FDA clearance for Jideytro for ROS1-positive NSCLC in rapid payoff from acquisition, marking British drugmaker's entry into lung cancer market.
BioPharma Dive · +6 outlets
Scribe secures $129M in rare gene editing IPO, first in two-plus years
Gene editing startup Scribe prices IPO at significantly lower valuation than typical 2026 biotech IPOs despite being first of its kind in over two years.
BioPharma Dive
FDA panel narrowly votes to allow compounding of unapproved peptides BPC-157, KPV
Regulatory panel recommended allowing compounding pharmacies to produce popular but unproven peptides despite safety concerns and limited evidence, marking win
BioPharma Dive · +5 outlets
Gene therapy approach installs hearing in children and adolescents born deaf
Paradigm therapy demonstrates ability to restore auditory function in deaf patients through genetic intervention.
Nature · +1 outlets
Supercooled kidneys successfully transplanted into pigs in landmark organ preservation achievement
Breakthrough in organ preservation technology extends transplant window and expands donor pool potential.
Biotechnology and health · +1 outlets
J&J bispecific combo reduces myeloma progression risk by 89% in phase 3 trial
Bispecific antibody combination shows substantial efficacy against multiple myeloma progression in late-stage testing.
Fierce Pharma · +8 outlets
Experimental Alzheimer's drug shows promise slowing cognitive decline in clinical trial
New approach targeting difficult protein demonstrates potential to slow cognitive progression in phase trial.
Smithsonian Magazine · +14 outlets
FDA approves Zidesamtinib for pretreated ROS1-positive NSCLC
New targeted therapy gains clearance for lung cancer patients with specific mutation.
Oncology Nursing News · +14 outlets
FDA clears next-generation gene therapy trial for Tay-Sachs and Sandhoff diseases
Regulatory clearance advances gene therapy development for rare genetic metabolic disorders.
trialsitenews.com · +1 outlets
VERAXA Biotech advances BiTAC-TCE cancer therapy with German regulatory guidance
VERAXA received positive regulatory feedback from German authorities on BiTAC platform and initiated cell line development for lead cancer program.
Yahoo Finance · +8 outlets
Arrowhead hits best-case scenario with latest results for fat-lowering drug plozasiran
RNAi therapy demonstrates apparent safety and effects on triglycerides and pancreatitis in testing.
BioPharma Dive · +3 outlets
Matt Wilsey built gene therapy for daughter, says FDA unprepared for next generation of treatments
Patient advocate and founder questions FDA readiness for novel gene therapy development models.
STAT · +1 outlets
Prime Medicine expects first-in-human Wilson disease trial in H2 2026
Gene therapy company on track to initiate early human testing for genetic rare disease treatment this year.
Stock Titan · +2 outlets
NovoCure stock soars 25% after record Q2 revenue and raised full-year guidance
Tumor-treating fields company posts strong financial results and raises outlook.
International Business Times Australia · +1 outlets
Crystalys raises $130M more to push gout drug through late-stage clinical testing
Series B funding supports global development of urate-lowering therapy approved in Asia.
BioPharma Dive · +5 outlets
European Medicines Agency takes steps to bolster clinical trial transparency
Regulatory action ensures public disclosure of clinical trial results as required by law.
STAT · +7 outlets
Celcuity gains FDA approval for new breast cancer drug with promising future outlook
Companion diagnostic-guided cancer therapy gains regulatory clearance.
Star Tribune · +6 outlets