Bristol Myers Squibb & 2Seventy Abecma Expands Approval for Multiple Myeloma Treatment
Abecma, a personalized CAR T cell therapy, has received expanded approval from the FDA for the treatment of adult...
Alnylam Unveils Positive KARDIA-2 Phase 2 Results for Zilebesiran in Hypertensive Patients
The KARDIA-2 Phase 2 study evaluated the efficacy and safety of zilebesiran, an RNAi therapeutic targeting hypertension, when added...
Merck Launches Phase 3 Trial with Combo of MK-1084 & KeytrudaⓇ for NSCLC Treatment
Merck has initiated a Phase 3 clinical trial (NCT06345729) to evaluate MK-1084, an oral KRAS G12C inhibitor, in combination...
FDA Grants 510(k) Clearance to Angiodynamics’ AlphaVac F1885 System for PE Treatment
AngioDynamics has received FDA clearance for the AlphaVac F1885 System to treat pulmonary embolism (PE), a life-threatening condition. PE...
Allurion Bridges Digital Gap, Introduces Virtual Care Suite in US
Allurion Technologies has launched its Virtual Care Suite (VCS) in the United States. It provides a comprehensive weight loss...
FDA On Clinical Trial Innovation and Regulatory Evolution
The Enhancing Adoption of Innovative Clinical Trial Approaches: FDA Convening conference hosted by Duke Margolis Institute for Health Policy,...
EC Approves Bristol Myers’ Reblozyl as First-Line Treatment for LR-MDS Anemia
The European Commission (EC) has expanded approval of Reblozyl (luspatercept), a first-in-class treatment for patients with disease-related anemia, for...
D&D Pharmatech Receives Fast Track Designation from FDA for DD01 – Novel Treatment for NASH/MASH
D&D Pharmatech, a biotech company, has been granted Fast Track designation by the US Food and Drug Administration (FDA)...
EMA Accepts Rocket Pharma’s RP-L102 Application for Fanconi Anemia Treatment
Rocket Pharmaceuticals, a late-stage biotechnology company, has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization...
US FDA Accepts Astrazeneca License Application for Datopotamab Deruxtecan in Metastatic HR+, HER2- Breast Cancer
Biopharmaceutical companies AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted in the US,...