CBS News says the federal patent office is taking steps to slow challenges to innovator biologic drug patents by biosimilar drug makers, while FDA is ...
A congressional commission on U.S.-China relations calls on Congress to authorize FDA to collect data from drug companies on where their drug componen...
FDA denies a citizen petition requesting that it warn patients about whether surgical mesh implanted off-label during cosmetic mastopexy procedures ma...
FDA and generic drug manufacturers kick off formal negotiations on the next cycle of the Generic Drug User Fee Amendments during a recent meeting at t...
Former CDER chemistry, manufacturing and controls (CMC) reviewer Fabiola Cervantes-Gomez joins Hyman, Phelps & McNamaras as a CMC regulatory expert.
Advocacy group Public Citizen petitions FDA to add new, class-wide pregnancy warnings to the labels of commonly prescribed serotonin reuptake inhibito...
FDA cites a direct-to-consumer television advertisement for AstraZenecas Farxiga (dapagliflozin) tablets.
Hims & Hers Health appoints former FDA Global Regulatory Operations and Policy deputy commissioner Deb Autor as its first chief policy officer.
