With the introduction of genAI tool Elsa at the FDA in June, the technology is playing a greater role in the medical device review process.

Investing.com -- Maia Biotechnology Inc (NYSE: MAIA) stock surged 11.2% in pre-market trading after the company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track ...

Investing.com -- Entera Bio Ltd (NASDAQ: ENTX) stock jumped 9.1% in pre-market trading after the FDA agreed that the company’s New Drug Application (NDA) for EB613 could use bone mineral density (BMD) ...

Investing.com -- Celcuity Inc. (NASDAQ: CELC) stock surged over 100% following the announcement of positive Phase 3 trial results for its breast cancer drug gedatolisib, which showed unprecedented ...

NetraMark Holdings Inc. (the “Company” or “NetraMark”) (CSE: AIAI) (OTCQB: AINMF) (Frankfurt: PF0) a premier artificial intelligence (AI) company transforming clinical trials and ...

Barclays (LON: BARC) views the development as “a small negative for Bayer,” though analysts remain positive on the drug’s ...

Data are Consistent with Phase 2 Double-Blind Trial and Support Advancement of ATH434 in MSA – MELBOURNE, Australia and SAN FRANCISCO, July 28, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH ...