FDA and the drug industry conclude technical negotiations over the next iteration of the Prescription Drug User Fee Act, setting the stage for broader political and congressional debate over the future direction FDA’s drug review program.
Replimune plans to resubmit its controversial BLA for RP1 (vusolimogene oderparepvec) in combination with Opdivo as a treatment for advanced melanoma following what the company described as productive discussions with the agency.
FDA and the drug industry conclude technical negotiations over the next iteration of the Prescription Drug User Fee Act, setting the stage for broader political and congressional debate over the future direction FDA’s drug review program.
Replimune plans to resubmit its controversial BLA for RP1 (vusolimogene oderparepvec) in combination with Opdivo as a treatment for advanced melanoma following what the company described as productive discussions with the agency.
An FDA crackdown on allegedly deceptive prescription drug advertising leads to a sharp increase in pharmaceutical advertising spending on television and streaming platforms, a new report finds.
FDA posts a draft guidance that proposes streamlined nonclinical safety testing approaches for certain oncology biologics and conjugated therapies.
