Ohio attorney general Mike DeWine sues five opioid manufacturers for fraudulent marketing of their prescription drug products.
Former FDA regulatory counsel Deborah Livornese joins Arnall Golden Gregory as counsel in its food and drug practice.
AssurX says FDAs emphasis on drug manufacturing quality as seen in recent Warning Letters is expected to continue.
FDA publishes the FDA-483 issued after an agency inspection at SterRx, a drug outsourcing facility.
FDA approves a Novo Nordisk BLA for Rebinyn to treat adults and children with hemophilia B.
Federal Register notice: FDA announces a 6/21-22 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting.
FDA accepts a Pfizer supplemental NDA for Sutent (sunitinib) seeking to expand its use to include adjuvant treatment in adult patients at high risk of...
Lupin Pharmaceuticals recalls one lot of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol) 1 mg/0.02 mg chewable and ferrous fumarate 75 mg ...