The Justice Department says kalo is paying $12.7 million to resolve a whistleblowers allegations that it induced false claims for its Evzio anti-opioi...
FDA clears a Vektor Medical 510(k) for vMAP, a computational electrocardiogram mapping system for use to improve outcomes in ablation procedures.
Childrens Health Defense calls for a congressional probe of FDAs handling of a whistleblowers complaint about poor research practices at a contractor ...
Federal Register news: FDA determines for patent extension purposes the regulatory review period for Ultragenyxs Dojolvi (triheptanoin).
Federal Register notice: FDA seeks comments on an information collection extension entitled Antimicrobial Animal Drug Distribution Reports and Recordk...
Biogen says it is investigating the death of a 75-year-old patient who had taken the companys controversial Alzheimers drug Aduhelm (aducanumab).
FDA says research it funded demonstrated that in two contexts shorter courses of antibiotic treatment were as effective as longer courses, reducing th...
The Consumer Healthcare Product Association recommends four steps FDA should take in implementing an appeals court decision on regulating drug/device ...