Clinical trials are a key driver of biotech stocks. Every new therapy must pass through a series of testing, Phase 1, Phase 2 ...
Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) ...
Why does it take a new drug 10 years, on average, to come to market? Part of the reason lies in the dead time in the process. Historically, trials have required tedious tabulations and repeated ...
Left to right: Lola Fashoyin-Aje, Steven Fleischer, Vijay Kumar, Travis Quigley, Rosanna Ricafort, Nirali N. Shah, and Chris White. (Source: FOCR) More flexibility in early-phase development for cell ...
LUCIA did not achieve the primary endpoint of statistical non-inferiority in mean change in BCVA versus on-label aflibercept control, despite ...
LA JOLLA, Calif., July 29, 2026 /PRNewswire/ -- CalciMedica, Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing calcium release-activated ...
(Milky Way/Moment RF/Getty Images) For those with celiac disease, even a little bit of gluten can cause damage to the intestine. The only available solution is a strict gluten-free diet. Yet even when ...
Clearance advances 8M2D, designed to inhibit β-amyloid production rather than clear plaque after it forms; first participant expected to be dosed in late 2026 LA JOLLA, Calif., June 17, 2026 (Newswire ...
Novel Nano-Amorphous Calcium Carbonate Technology Platform Aims to Maintain Optimal Serum Calcium Levels Using Half the Elemental Calcium Dose of Conventional Treatments NES ZIONA, Israel, July 28, ...
The FDA-aligned pivotal efficacy population includes 12 male patients receiving commercial-grade RP-A501 at the recalibrated dose. The first three patients treated under the modified protocol count ...
Arrowhead is now moving its tau-targeting therapy from healthy volunteers to Alzheimer’s disease patients.
On August 18, 2026, in Japan, the Department of New Experimental Therapeutics and Early-Phase 1 Drug Development Service at Kansai Medical University Hospital, led by Professor Toshio SHIMIZU, ...