May 14th 2024
In the Phase IIIa FRONTIER 2 trial, participants aged 12 years and older administered Mim8 showed significant and superior reduction of treated bleeding episodes.
FDA to Evaluate BLA for Datopotamab Deruxtecan in Non-Small Cell Lung Cancer
February 20th 2024The FDA set a Prescription Drug User Fee Act date during Q4 of 2024 for the biologics license application for datopotamab deruxtecan in patients with previously treated advanced nonsquamous non-small cell lung cancer.
Bristol Myers Squibb Seeks Approval for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer
February 7th 2024Results from the Phase III CheckMate -77T trial show that Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo produced statistically significant and clinically meaningful improvements in event-free survival in patients with resectable stage IIA to IIIB non-small cell lung cancer.
GSK's Blenrep Produces Significant Survival Improvement in Relapsed or Refractory Multiple Myeloma
February 6th 2024Patients with relapsed or refractory multiple myeloma administered Blenrep combined with bortezomib plus dexamethasone experienced a 59% reduction in the risk of disease progression or death compared with the standard of care.
FDA Fast Tracks Antibody-Drug Conjugate for Ovarian, Fallopian Tube, Primary Peritoneal Cancers
February 6th 2024BioNTech SE and Duality Biologics' next-generation antibody-drug conjugate is being evaluated for patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer previously administered one to three systemic treatment regimens.
Astellas Announces Submission of sNDA for Padcev/Keytruda Combo for Urothelial Cancer
January 31st 2024Approval sought for Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab) for the first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer, which would be the first approved combination alternative to platinum-containing chemotherapy for this patient population.
FDA Approves Takeda's Gammagard Liquid for Chronic Inflammatory Demyelinating Polyneuropathy
January 30th 2024This is Takeda's second approval in chronic inflammatory demyelinating polyneuropathy this month after the FDA approved HyQvia to protect against relapse of neuromuscular disability and impairment in this patient population.
Sarepta's Novel Drug for Duchenne Muscular Dystrophy Shows Favorable Efficacy to Eteplirsen
January 30th 2024SRP-5051 administered every four weeks produced higher increases in dystrophin and exon skipping compared to eteplirsen dosed weekly in patients with Duchenne muscular dystrophy amenable to exon 51 skipping.