FDA approves an Arrowhead Pharmaceuticals NDA for Redemplo (plozasiran) for reducing dangerously high triglyceride levels in adults with familial chyl...
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...
