Inovio wins FDA accelerated approval for Voceryq, first DNA immunotherapy for recurrent respiratory papillomatosis
The accelerated nod for the plasmid DNA therapy is the first US approval of its kind for the rare airway disease, and the surrounding coverage notes a sharp aft
Tech Times · +14 outlets
Genmab reports head and neck bispecific data that cut risk of death by 50 percent, fueling a $10B stock week
Strong results for Genmab's bispecific cancer drug lifted the company's market value sharply, making it one of the standout data reads of the ESMO conference.
Drug Discovery News · +14 outlets
FDA approves Moderna's mRNA seasonal flu vaccine
The clearance marks a first for an mRNA-based seasonal flu shot and expands Moderna's commercial mRNA franchise beyond Covid.
RTTNews · +13 outlets
Personalized mRNA melanoma vaccine results hailed as a major step forward
Investigators and clinicians say the individualized mRNA cancer vaccine reduced the risk of melanoma recurrence, a closely watched test of the modality beyond i
The Institute of Cancer Research (ICR) · +10 outlets
Merck and Moderna's mRNA cancer vaccine assessed as ESMO oncology data draw scrutiny
Analysts and reporters weighed the personalized cancer vaccine data alongside broader questions about how far mRNA platforms can extend into oncology.
STAT · +9 outlets
Pelthos Therapeutics to merge with Castle Creek Biosciences in deal worth up to $300M in milestones
The combination pairs the two companies around a rare skin-disease therapy, with Pelthos shares falling sharply after the agreement was disclosed.
citybiz · +8 outlets
Acumen scraps sole asset after Alzheimer's failure, stock plunges 80 percent
The setback leaves the company without a clinical pipeline and wipes out most of its market value.
BioSpace · +1 outlets
Gilead discloses partial clinical hold on two CAR-T cell therapy trials
The regulatory action pauses parts of the company's CAR-T development programs while the issue is reviewed.
Fierce Biotech · +1 outlets
First patient receives stem cell treatment for Parkinson's disease in pioneering transplant
The procedure marks an early clinical test of cell replacement therapy for Parkinson's and a notable milestone for regenerative medicine.
Medical Xpress · +4 outlets
Dren Bio raises $350M to push rare blood cancer therapy toward market
The financing gives the company capital to advance its bispecific antibody program in rare blood cancers.
BioXconomy · +3 outlets
Regeneron reports 'clean sweep' in Q3 with multiple pipeline catalysts ahead
The company posted broad-based quarterly strength and flagged several upcoming readouts across its pipeline.
BioSpace · +1 outlets
UK clears Casgevy gene therapy for children as young as five, NHS funding unresolved
The expanded label widens access to the CRISPR-based sickle cell and beta thalassemia therapy, though reimbursement remains unsettled.
Tech Times · +4 outlets
FDA approves first antisense treatment for hepatitis B, offering functional cure in about one in five patients
The new antisense drug provides an alternative for hepatitis B patients who can achieve a functional cure with treatment.
Labroots · +14 outlets
AstraZeneca cuts early-phase prostate cancer pipeline and launches $1.5B annual cost-cutting program
The pipeline trim and three-year savings plan reflect AstraZeneca's effort to redirect spending toward R&D priorities.
STAT · +4 outlets
Iovance adds biomarker selection to lifileucel lung cancer trial after Phase 2 data, stock crashes on surprise twist
The company is narrowing its lung cancer trial population with biomarker selection following mixed Phase 2 results that rattled investors.
The Clinical Trial Vanguard · +7 outlets
Samsung Bioepis seeks US approval for Keytruda biosimilar SB27 across 18 cancer indications
The filing adds to the wave of biosimilar challenges to Merck's blockbuster checkpoint inhibitor.
헬스조선 · +6 outlets
Pretzel Therapeutics wins UK authorization to advance PX578 into Phase II for rare mitochondrial disease
The UK regulatory green light moves the program into patient trials for POLG-mediated primary mitochondrial disorders.
BioPharma APAC
Merck to raise next-decade revenue forecast on optimism over new drugs
The company is betting its pipeline can offset eventual patent losses on key products.
pharma.economictimes.indiatimes.com · +1 outlets