Moderna says its bivalent Covid vaccine booster specifically targeting the Omicron variant achieved superior antibody response against Omicron and cou...
CDER issues a MAPP outlining the roles and responsibilities of the Office of Generic Drugs and Office of Surveillance and Epidemiology in assessing th...
Lawmakers introduce a bill to ensure access to over-the-counter oral birth control drugs.
Global Forum representatives from 12 major drug companies call for a Covid-19-like approach to therapies for other significant diseases and conditions...
The Association for Accessible Medicines says it is concerned that FDA does not have statutory authority for its proposed quality metrics program.
Sens. Marshall and Braun propose legislation to limit how FDA communicates medical device safety information.
FDA approves Sanofis Dupixent (dupilumab) for children aged six months to five years with moderate-to-severe atopic dermatitis whose disease is not ad...
Outlook Therapeutics says it has withdrawn a BLA submitted in March for Lytenava (bevacizumab-vikg) for treating wet age-related macular degeneration ...