FDA grants Allogene Therapeutics three fast track designations for ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T cell therapy ...
A Senate HELP Committee postpones a hearing tentatively planned for 4/10 because HHS secretary Robert F. Kennedy, Jr. reportedly could not appear this...
Rhythm Pharmaceuticals announces positive topline results from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide for treating acquired hypo...
FDA accepts for review a Teva Pharmaceuticals supplemental BLA for Ajovy (fremanezumab-vfrm) to expand the indication to include preventing episodic m...
Former CDRH director Jeff Shuren says recent staff cuts at CDRH will likely lead to longer review times.
FDA approves an Amgen supplemental BLA for Uplizna (inebilizumab-cdon) for treating adults living with immunoglobulin G4-related disease.
HHS secretary Robert F. Kennedy Jr. admits that many mistakes were made in cuts across HHS health agencies, including FDA, and that around 20% of term...
The U.S. House Committee on Oversight and Government Reform announces a 4/9 hearing on reducing inefficiencies and the bureaucracy at FDA.
