A new journal article finds substantial differences in how major international regulators evaluate and approve oncology drugs that first receive exped...
Former FDA commissioner Scott Gottlieb urges federal health officials to restore scientific leadership at the agency's medical product centers.
Former FDA Office of New Drugs director Peter Stein criticizes the agency's National Priority Voucher program at the DIA Global Annual Meeting in Phil...
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...
