Becker's Hospital Review

FDA proposes new framework for clinical drug trial designs

FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

US, European regulators set principles for 'good AI practice' in drug development

The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe and responsible ...

Ainnocence and Phase Advance Enter Industry-First AI Collab to Reduce Drug Development Timeline and Clinical Trial Risk

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

FDA Proposes Sweeping Changes to Accelerate Biosimilar Development

Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...
JD Supra

FDA Proposes Incentives for Domestic Drug Development in PDUFA Negotiations

In recent months, pharmaceutical industry stakeholders and the U.S. Food and Drug Administration (FDA) began formal negotiations on fee levels ...
Targeted Oncology

FDA Type B Meeting Offers Direction for Rhenium Re 186 Obisbemeda in LM

A Type B meeting between the FDA and Plus Therapeutics offered clarity and direction for the next steps in development of ...

Global Development Accelerates: Leads Biolabs' PD-L1/4-1BB Bispecific Antibody Granted Fast Track Designation by FDA

Nanjing Leads Biolabs Co., Ltd. (HKE: 9887) ("Leads Biolabs" or the "Company") today announced that Opamtistomig (LBL-024), its core investigational PD-L1/4-1BB bispecific antibody, has been granted ...