Trevena resubmits its NDA for oliceridine for managing moderate-to-severe acute pain.
Pfizer and Astellas Pharma report study data demonstrating a statistically significant improvement in overall survival in men with non-metastatic cast...
FDA releases its latest batch of Warning Letters that includes one medical product company Marco Pharma.
FDA and BrainStorm Cell Therapeutics agree on a potential regulatory approval path for NurOwn to treat ALS.
FDA puts a clinical hold on LogicBio Therapeutics LB-001 IND being investigated to treat methylmalonic acidemia.
Washington Legal Foundation asks the 9th Circuit Court of Appeals to enjoin a California law that presumes most drug patent settlements are unlawful....
The Office of Pharmaceutical Quality 2019 annual report looks at the progress made in the organizations five years of existence.
FDA lifts its clinical hold on a Marker Therapeutics trial of its novel MultiTAA T-cell therapy for some acute myeloid leukemia patients.