The FDA is expected to decide on treatments for Alzheimer disease agitation, focal segmental glomerulosclerosis, hematological malignancies, HIV-1, and obesity.
CEO Jacqueline Shea highlighted that "these are very exciting times for Inovio with our first BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis or RRP, ...
Data support potential of isaralgagene civaparvovec as a one-time, well tolerated and durable Fabry disease gene therapy to provide meaningful, ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
The Food and Drug Administration (FDA) has issued a Refuse-to-File (RTF) letter to Moderna, Inc. regarding its Biologics License Application (BLA) for the investigational mRNA-based influenza vaccine ...
FDA's elevated meeting status signals transition from biomarker data discussions to Accelerated Approval discussions OS ...
AxoGen (NASDAQ:AXGN) executives said a newly secured Biologics License Application (BLA) approval has preserved the company’s ability to serve patients across a broad range of peripheral nerve repair ...
STAAR study demonstrated positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study, which U.S. Food and Drug Administration (FDA) ...