FDA approves Spark Therapeutics Luxturna for treating patients with a form of retinal dystrophy.
FDA says it will take a new risk-based enforcement approach to homeopathic drugs that are marketed for serious illnesses or dont have demonstrated cli...
Senators Grassley and Klobuchar ask FDA if the non-enforcement policy for some drug importation from Canada has changed.
FDA clears Xcision Medical Systems GammaPod breast cancer radiation treatment.
FDA allows marketing of Sanuwaves Dermapace System to treat diabetic foot ulcers in adult patients with pulses of energy to mechanically stimulate the...
CDER innovative drug approvals sharply rebound in 2017 more than doubling the 22 products approved in 2016, which was a significant down year for app...
FDA releases two guidances on communications with drug sponsors.
Washington Legal Foundation asks the Supreme Court to hear Pfizers appeal of a 3rd Circuit Appeals Court decision on a patent settlement between Pfize...