Zealand Pharma submits an NDA for HypoPal (dasiglucagon) rescue pen for treating diabetes patients with severe hypoglycemia.
New York University researchers say that a comparative study showed that Abbott Laboratories ID Now Covid-19 rapid test missed a third of the samples ...
Federal Register notice: FDA sends to OMB an information collection extension for Adverse Event Program for Medical Devices (Medical Product Safety Ne...
Federal Register notice: FDA seeks comments on an information collection extension entitled Certification to Accompany Drug, Biological Product, and D...
CDRH policy analyst Allen Hill explains the voluntary 510(k) third-party review program in a Webinar presentation.
CBER releases the transcript from a 3/3 public workshop on individualized therapeutics regulated by the Center.
FDA issues a refusal to file letter to Bristol Myers Squibb and Bluebird Bio for a BLA for idecabtagene vicleucel, indicated for treating patients wit...
MasterPharm recalls one lot of finasteride plus 1.25mg capsules because they were found to contain higher levels of minoxidil, an antihypertensive dru...