FDA accepts for review a CSL Behring clinical efficacy supplement on its BLA for to Privigen [immune globulin intravenous (human), 10% liquid], seekin...
FDA releases its latest batch of Warning Letters that cites seven firms three medical device makers and four pharmaceutical firms.
Hyman, Phelps & McNamara attorney Anne Walsh says a False Claims Act settlement last month by Baxter Healthcare was unusual because it was not an off-...
Zosano Pharma says it is planning an NDA for its migraine drug M207 after reporting clinical trial (ZOTRIP) results where both co-primary endpoints of...
FDA partially approves an Alcon citizen petition that asked the agency to require only in vivo bioequivalence testing for ANDAs that cite its Ciprodex...
FDA approves an updated label for Eli Lillys once-weekly Trulicity (dulaglutide) to include use in combination with basal insulin for adults with Type...
Washington Legal Foundation asks the U.S. Supreme Court to review and ultimately overturn a divided Eighth Circuit ruling that upheld a term of impris...
Aeterna Zentaris says it is planning to seek FDA approval for Macrilen (macimorelin) for evaluating growth hormone deficiency in adults.