The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion under accelerated review, recommending lenacapavir, the company’s [Read More…]
AstraZeneca announced that its novel nanobody, gefurulimab, has successfully met its primary and all secondary endpoints in the PREVAIL Phase III trial for adults with generalized myasthenia gravis (gMG). The results showed that the once-weekly, self-administered treatment delivered statistically significant and clinically meaningful improvements in daily living activities for patients with this rare autoimmune disease.
The European Commission (EC) has granted a landmark approval for Johnson & Johnson’s DARZALEX® (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma (SMM). This decision marks a significant shift in the treatment paradigm for this precursor to active multiple myeloma, moving away from the traditional “watch and wait” approach to proactive, early therapeutic intervention.
A groundbreaking real-world study has revealed that Beyfortus (nirsevimab-alip) significantly reduces the incidence of respiratory syncytial virus (RSV) disease in infants. The largest of its kind in the United States, the study demonstrated an 87% reduction in RSV cases requiring a visit to a doctor or hospital and a 98% decrease in hospitalizations among infants who received the treatment.
AstraZeneca has announced a landmark $50 billion investment in the United States through 2030, a strategic initiative designed to significantly enhance America’s leadership in pharmaceutical innovation.
AstraZeneca announced groundbreaking results from its FLAURA2 Phase III trial, revealing that Tagrisso (osimertinib) combined with chemotherapy offers a statistically significant and clinically meaningful improvement in overall survival for patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC).
Genentech, a member of the Roche Group, announced Friday that the U.S. Food and Drug Administration (FDA) has rejected its application to expand the use of its cancer drug Columvi® (glofitamab-gxbm). The FDA issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA), effectively declining to approve Columvi in combination with chemotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Eight healthy babies have been born in the UK using a revolutionary “three-person IVF” technique called mitochondrial donation. This groundbreaking procedure, led by scientists at Newcastle University, successfully prevents the transmission of incurable, inherited genetic diseases from mother to child, offering new hope to families worldwide.
The U.S. Food and Drug Administration (FDA) has given the green light to a new, prefilled syringe presentation of GSK’s highly effective shingles vaccine, Shingrix.
Johnson & Johnson announced robust second-quarter 2025 financial results, surpassing analyst expectations and raising its full-year guidance. The healthcare giant reported a significant 5.8% increase in sales to $23.7 billion, driven by strong performances in its Innovative Medicine and MedTech segments.
