Vaccine Candidate Gets Orphan Drug Status for Glioblastoma Treatment
VBI-1901 is an investigational bivalent eVLP vaccine immunotherapeutic candidate designed to target 2 highly immunogenic CMV antigens, gB and pp65.
Diagnosis & Disease Information
Omburtamab Gets Priority Review for Neuroblastoma
Omburtamab is an investigational radiolabeled monoclonal antibody designed to target tumor cells that express B7-H3.
Bevacizumab Biosimilar Alymsys Gets FDA Approval
The approval was based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents.
FDA Rejects Pedmark NDA Again Citing Manufacturing Deficiencies
The application could not be approved in its present form due to manufacturing deficiencies.
Novel Therapy for Diffuse Intrinsic Pontine Glioma Fast Tracked
Oblato plans to evaluate OKN-007 for diffuse intrinsic pontine glioma in a phase 1/2 trial this year.
Potential Med Errors Prompt FDA Action on Vinca Alkaloid Labeling
Chemotherapy agents such as vincristine sulfate injection, vinblastine sulfate injection, and vinorelbine tartrate injection should only be prepared in IV infusion bags.
New Drugs Approved in 2020
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
MPR Weekly Dose Podcast Episode 60
This week the FDA and the WHO have a back and forth over remdesivir; Who should get a COVID vaccine; Xolair and Hetlioz have approval expansions; And a novel neuroblastoma treatment gets accelerated approval.
Novel Treatment Gains Accelerated Approval for Relapsed/Refractory Neuroblastoma
Approval was based on results from two phase 2 single-arm, open-label trials that demonstrated overall response rate and duration of response.
FDA Grants Orphan Drug Status to Berubicin for Malignant Gliomas
he designation is supported by data from a phase 1 trial conducted by Reata Pharmaceuticals in 2016. Findings from the study showed 44% of patients treated with berubicin (n=11 out of 25) experienced a statistically significant improvement in progression free survival.
