Federal Register notice: FDA establishes a docket to solicit comments on the content of Appendix A in the 7/2018 guidance for industry entitled ANDA S...
A new drug pricing analysis finds that for drugs launched so far this year, their median pricing ($257,000) is 43% more than the median pricing of dru...
FDA issues Emergent BioSolutions an 8/10 Warning Letter after a February inspection cites GMP issues at its Camden, MD manufacturing facility.
French national and Hexim Pharmaceuticals chief executive officer Alain Bouaziz pleads guilty to making false statements to FDA to gain control of the...
Gilead Sciences files a sBLA for Trodelvy (sacituzumab govitecan-hziy), seeking expanded approval in patients with HR+/HER2- metastatic breast cancer....
Medtronic recalls its Cobalt and Crome implantable cardioverter defibrillators because the devices have the potential for reduced shock energy (about ...
FDA clears a Dyad Medical 510(k) for its echocardiogram application called Echo:Prio.
Weeks after being administered a Novartis gene therapy, two children die of acute liver failure, according to the company.
