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 ...

Treatments for Alzheimer disease agitation, focal segmental glomerulosclerosis, hematological malignancies, HIV-1, and obesity are under review.

FDA's elevated meeting status signals transition from biomarker data discussions to Accelerated Approval discussions OS ...

Data support potential of isaralgagene civaparvovec as a one-time, well tolerated and durable Fabry disease gene therapy to provide meaningful, ...

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, ...

MELVILLE, N.Y., Nov. 17, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX) , a ...

FDA reinspection, apitegromab BLA resubmission and 2026 launch outlook, plus cash and new debt facility—read now.

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 ...

In the fifth part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss key considerations for biologics license applications (BLAs) and the Food and Drug ...

Spruce Biosciences Inc has announced a revised schedule for its regulatory submission of TA-ERT, a potential treatment for Sanfilippo syndrome type B. While the ...

Detailed price information for Larimar Therapeutics Inc (LRMR-Q) from The Globe and Mail including charting and trades.