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Merck stops a Phase 3 KEYLYNK-008 trial evaluating anti-PD-1 therapy Keytruda (pembrolizumab) in combination with maintenance Lynp...[ Price : $8.95]
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for QED Therapeutics Truse...[ Price : $8.95]
ProPublica and the Pittsburgh Post-Gazette take aim at alleged FDA failures to properly manage a timely response to reports of pro...[ Price : $8.95]
FDA publishes a draft guidance with an interim enforcement discretion policy for some Section 503 drug compounding using bulk drug...[ Price : $8.95]
FDA clears a Becton Dickinson 510(k) for what it describes as a novel blood collection device that gathers blood samples from a fi...[ Price : $8.95]
Sen. Elizabeth Warren and Rep. Jan Schakowsky reintroduce their bill to establish a generic drug manufacturing operation within HH...[ Price : $8.95]
FDA extends by three months its review of an Optinose supplemental NDA for Xhance (fluticasone propionate) as a treatment for chro...[ Price : $8.95]
FDA publishes an interim policy delaying regulatory action on drug compounding using bulk drug substances while the agency develop...