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) ...

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

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, ...

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

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

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 ...

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

The FDA accepted a Biologics License Application for imlifidase for the desensitization treatment of highly sensitized adult kidney transplant patients.

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

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 ...

RICHMOND, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, has initiated a rolling submission of a BLA to the FDA seeking accelerated ...