The Justice Department says Astellas and Amgen will pay a total of $124.75 million to resolve charge that they paid illegal kickbacks to patients to u...
Eli Lilly says it is withdrawing rare cancer drug Lartruvo (olaratumab) from the market based on data from a confirmatory trial in which the drug did ...
The Justice Department says two former Arriva executives are paying $500,000 each to resolve False Claims Act cases against them involving Medicare cl...
Federal Register notice: FDA makes available a draft guidance entitled Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics ...
Federal Register notice: FDA makes available a final guidance entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Sto...
FDA issues a guidance to help government stakeholders know if they can extend the expiration date of stockpiled doxycycline, confident that it has ret...
FDA releases a draft guidance on adjusting for covariates in clinical trials for drugs and biologics with continuous outcomes.
Federal Register notice: FDA makes available a draft guidance entitled Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.