The Phase II trial will assess the early efficacy, safety and pharmacokinetics of combining elisrasib with D3S 002.

The FDA has accepted an investigational new drug application from a global biotechnology company for its investigational, ...

Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis (OA), today announces the US Food and Drug Administration (FDA) has accepted ...

The FDA has accepted an investigational new drug application for an investigational and proprietary combination therapy to ...

FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...

The Phase 1/2 trial is a first-in-human, open-label, multi-national study designed to evaluate the safety, tolerability, and efficacy of TSRA-196 in adults with AATD. Trial participants will receive a ...

D3 Bio, a global clinical‑stage biotechnology company focused on developing transformative oncology therapeutics, today ...

The US Food and Drug Administration (FDA) has cleared GenEditBio Limited’s Investigational New Drug (IND) application to initiate phase 1/2 CLARITY trial activities for its lead in vivo genome-editing ...

Moving Biotech (4MB), a clinical stage biotechnology company developing next-generation, disease-modifying therapies for osteoarthritis (OA), today announced that the U.S. Food and Drug Administration ...

First patient dosed and study open in leading oncology centers in US and AustraliaPhase I/IIA adaptive study aims to assess and optimize the dose of OTP-01 and provide safety, tolerability, ...

“Let it grow, let it blossom,” said Eric Clapton, and so the Food and Drug Administration expects of expanded access programs with the issuance of its guidance on “Expanded Access to Investigational ...

The collaboration marks a turning point in AI-driven drug design and trial forecasting, de-risking the drug development ...