FDA grants Boehringer Ingelheim a breakthrough therapy designation for Hernexeos (zongertinib) tablets for the first-line treatment of certain adults ...
CDER and CBER launch the Rare Disease Evidence Principles process intended to bring greater speed and predictability to the review of rare disease the...
Memos posted on FDAs Web site from CBER director Vinay Prasad suggest the agency is raising the bar on future Covid-19 vaccination approvals.
FDA accepts for review an Achieve Life Sciences NDA for cytisinicline, an investigational treatment for helping those seeking to quit smoking.
Reuters reports that drug manufacturers are turning to artificial intelligence to reduce animal testing and cut costs and time in drug development.
FDA warns Castle Rock, CO-based Compounders International Analytical Laboratory about CGMP violations and deviations in its work testing drugs and act...
FDA publishes the 2025 OTC drug monograph forecast showing eight items it expects to address over the next three years.
FDA approves two new denosumab biosimilars from Shanghai Henlius Biotech and Organon for treating osteoporosis and cancer-related bone conditions.
