FDA warns Unetixs Vascular about illegally marketing adulterated and misbranded vascular diagnostic ultrasound devices.
FDA reaffirms support for decentralized clinical trials (DCTs) while making clear that moving trial activities outside traditional research sites does...
FDA commissioner Marty Makary forcefully defends the agency against mounting criticism of recent drug rejections, arguing the agency is following the ...
FDA sends a Warning Letter to CareFusion, citing widespread and repeat violations of current good manufacturing practice regulations at a Texas facili...
FDA issues an untitled letter to Bayer HealthCare Pharmaceuticals, citing misleading direct-to-consumer advertising for its prostate cancer drug Nubeq...
FDA commissioner Marty Makary outlines his goals to overhaul how the agency reviews new drugs, aiming to reduce early-stage regulatory friction, accel...
New Bloomberg reporting that FDA is facing mounting internal strain and external criticism just over a year into commissioner Marty Makarys tenure.
Clene says it plans to submit an NDA in the third quarter for its experimental amyotrophic lateral sclerosis therapy.
