Roche says its investigational selective estrogen receptor degrader giredestrant significantly improved invasive disease-free survival in certain peop...
FDA warns Opa-Locka, FL-based World Perfumes about CGMP violations in its production of finished drugs as a contract manufacturer.
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 warns North Bergen, NJ-based DermaRite Industries about CGMP, unapproved new drug, and misbranded drug violations in its production of over-the-co...
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.
