Shorter trial authorisation timelines for ATMP trials in the US are an advantage for biotechs, say experts. Although the ...

Precigen (PGEN) reported better-than-expected first-quarter earnings and is making strides toward commercializing its lead ...

Planned single, pivotal Phase 2/3 clinical trial, if positive, acceptable for Biological License Application (BLA) submission for Alzheimer’s ...

LGVN READ THE FULL LGVN RESEARCH REPORT Longeveron (NASDAQ:LGVN) is a company that should be getting more attention from investors and the just released annual results again proved that point. LGVN ...

FDA granted priority review to Company's BLA for PRGN-2012 for the treatment of adults with recurrent respiratory papillomatosis and set PDUFA target action date ...

FDA granted priority review to Company's BLA for PRGN-2012 for the treatment of adults with recurrent respiratory papillomatosis and set ...

Type B Meeting Discussion to Accelerate XRx-026 for Gout to NDA CALGARY, Alberta, March 19, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the "Company") (NASDAQ: XRTX | TSXV: XRTX | Fra ...

Inovio plans to begin submitting the BLA for INO-3107 in mid-2025, with a goal of achieving FDA acceptance for filing by year-end 2025. Priority review will also be requested.

The Company will provide further updates following communications with the FDA when additional information is available.

Inovio Pharmaceuticals Inc (INO) addresses manufacturing issues and progresses towards BLA submission, despite financial ...

Operator Good afternoon, ladies and gentlemen, and welcome to the INOVIO Pharmaceuticals fourth quarter 2024 financial results conference call. At this time, all lines are in listen-only mode.