The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric ...
Feeling stuffy and ready to reach for NyQuil, Benadryl, or Sudafed PE? Not so fast. The Food and Drug Administration (FDA) has proposed ending the use of oral phenylephrine, a common ingredient found ...
Commercial launch of neffy® (epinephrine nasal spray) underway in the United StatesSupplemental NDA for neffy®1mg dose granted priority review by FDA; PDUFA target date set for March 6, 2025Exclusive ...