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 ...

INOVIO (NASDAQ: INO) released its financial results and operational highlights for 2024, marking significant strides in its ...

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 ...

MMS, an award-winning, data-focused clinical research organization (CRO), is showcasing its expansion as a tech-enabled, full-service Risk Evaluation and Mitigation Strategies (REMS) solutions ...

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.