Mesoblast Says Resumbits Biologic License Application To FDA For Remestemcel-L In Children With With Steroid-Refractory Acute Graft Versus Host Disease (Sr-aGVHD)
Validation of Remestemcel-L Potency Assay used in the Phase 3 Trial which Measures In-Vivo Activity based on Mechanism of Action
Assay Identifies High-Potency Product Lots Associated with Enhanced Survival
New Data Show that Remestemcel-L Improves Inflammatory Biomarkers and Survival in Children at Highest Risk of Mortality
February PDUFA Catalysts Biotech Investors Must Know: Sanofi’s Bleeding Disorder Drug, Regeneron’s Twin Eylea Label Expansions, 3 Delayed Approvals And More
The year has started well for biopharma companies on the regulatory front, as most decisions handed out during January were positive. The Food and Drug Administration has already cleared four new molecular entities for the year.
ChromaDex Shares Promising Findings From A Clinical Study Showcasing Combined Metabolic Activators, Featuring Nicotinamide Riboside, Improved Cognitive Functions In Alzheimer’s Disease Patients
This first-of-its-kind human clinical study in AD patients showcased CMA supplementation significantly improved cognitive function and associated biomarkers
ChromaDex Corp. (NASDAQ:CDXC), a global bioscience company
Medtronic Recalls Over 22,000 Hemodialysis Catheters For Potential Hub Defect
Medtronic Plc (NYSE:MDT) is recalling around 22,700 hemodialysis catheters due to a possible defect in the device’s hub that…
‘Retractable Technologies Gets Australian Therapeutic Goods Administration Approval For A Single-use, Sterile Hypodermic Needle’ – Australian Gov
https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=403913&agid=(PrintDetailsPublic)&actionid=1
FDA Has Granted Breakthrough Therapy Designation To Moderna’s Respiratory Syncytial Virus Vaccine Candidate, mRNA-1345
The designation is based on topline data from the ConquerRSV Phase 3 efficacy trial, which demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease.The designation is based on topline data from the ConquerRSV Phase 3 efficacy trial, which demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease.
FDA Gives Conditional Approval For Eli Lilly’s Drug For Rare Blood Cancer
The FDA approved Eli Lilly And Co’s (NYSE:LLY) Jaypirca (pirtobrutinib) for adult patients with relapsed or refractory mantle cell lymphoma (MCL)…
Regeneron, Sanofi Announced Earlier , Dupixent Recommended For Expanded EU Approval By The CHMP To Treat Children As Young As Six Months Old With Severe Atopic Dermatitis
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent® (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy.