FDA places a clinical hold on Bellicum studies of BPX-501 while investigating whether three cases of encephalopathy are related to the drug.
Two Hyman, Phelps & McNamara attorneys say a Justice Department decision not to enforce cases based on allegations that agency guidance documents are ...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Mercks Keytruda (pembrolizumab) to be 1,338 day...
Federal Register notice: FDA plans a 4/16 public meeting on Evaluating Inclusion and Exclusion Criteria in Clinical Trials.
President Donald Trump acknowledges FDA and its record approvals last year in his 1/30 State of the Union address while also outlining public health p...
Alkermes files an NDA for ALKS 5461 (buprenorphine and samidorphan), a once-daily, oral investigational drug for the adjunctive treatment of major dep...
The Justice Department says a federal court accepted a guilty plea as part of a plea bargain in connection with fraudulent sales of QLasers.
FDA says the Sterile PRP Separation Kit is being sold without a valid PMA or IDE in effect.