In RFK Jr., drugmakers face an antagonist with regulatory power
Anxious and bewildered, some drugmakers are reaching out to their lobbyists about how Robert Kennedy’s pending nomination ...
RFK Jr. vow to purge FDA sets up collision with Big Pharma
Kennedy has been most vocal about the FDA, an agency that oversees nearly $3 trillion in medicines, food and tobacco products ...
BioSpace1d
PTC Wins First FDA Nod for Direct-to-Brain Gene Therapy, Targets Ultrarare Disease
The FDA has followed in the footsteps of its European counterparts and granted accelerated approval to PTC Therapeutics’ gene ...
medtechdive3d
J&J’s Ottava surgical robot to begin clinical trial after FDA nod
With FDA approval of an investigational device exemption, J&J’s soft tissue robot moves a step closer to challenging ...
BioPharma Dive4d
FDA lifts pause on Novavax flu vaccine trials
After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and ...