Former FDA chief of staff Elizabeth Jungman joins law firm Hogan Lovells as a partner in its pharmaceuticals and biotechnology practice in the Washing...
Vertex Pharmaceuticals says it will not pursue its investigational VX-993 as monotherapy for acute pain following bunionectomy surgery due to its fail...
FDA grants Dyne Therapeutics a breakthrough therapy designation for DYNE-251 for treating patients with Duchenne muscular dystrophy that is amenable t...
FDA grants TransMedics Group conditional approval to begin its next-generation Organ Care System ENHANCE heart trial.
Philips Respironics recalls (Class 1 device correction) its V30, A30, and A40 ventilators to update their use instructions due to the risk of failure ...
Anixa Biosciences assumes full sponsorship of a Cleveland Clinic IND for ian experimental breast cancer vaccine as it heads towards a Phase 2 clinica...
A new report from STAT describes drug review turmoil at FDA that led to FDA Oncology Center of Excellence director Richard Pazdur overriding CBER revi...
HHS acting general counsel Sean Keveney is appointed FDAs new chief counsel.
