An opinion article calls on FDA to establish a formal regulatory framework for evaluating vaccines as potential interventions to prevent dementia, arg...
Merck says FDA has approved an expanded indication for its pneumococcal conjugate vaccine, Capvaxive, allowing its use in children and adolescents age...
FDA approves a Beam Therapeutics IND for BEAM-304, allowing the company to begin clinical testing of its experimental base-editing treatment for pheny...
FDA approves the first generic version of Xofluza (baloxavir marboxil), clearing Norwich Pharmaceuticals' generic tablets for the treatment and preven...
Sens. Shaheen and Collins call on FDA to modify the regulatory pathway for deceased donor islet cell transplantation for some Type 1 diabetes patients...
Medical device expert Marcelo Trevino analyzes for Med Device Online the results from the first 100 FDA inspections under the new Quality Management S...
FDA releases a guidance that is intended to assist industry in the submission of datasets from clinical studies that evaluate immunogenicity and its i...
Sen. Ron Johnson (R-WI) launches a new investigation into federal handling of Covid-19 vaccine safety issues, seeking records from HHS, FDA and CDC re...
