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...
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 ...
FDA issues a Warning Letter to Cdymax India Pharma Private Limited after inspectors uncovered CGMP violations at the companys active pharmaceutical in...
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 warns Noblesville, IN-based Verdure Sciences about failing to submit an IND for a clinical study of its investigational drug Maplifa.
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...
