Abbott Laboratories and its spin-off AbbVie agree to pay $25 million to resolve allegations that they used kickbacks and off-label marketing and promo...
FDA inspects a Minnesota medical center and finds violations that subjected unwitting patients to dangerous and unethical human testing, according to ...
FDA approves a Jazz Pharmaceuticals supplemental NDA to revise labeling for Xyrem (sodium oxybate) oral solution to include an indication to treat cat...
FDA Review posts the Federal Register notices for the week ending 10/26/2018.
FDA accepts for priority review a Taiho Oncology supplemental NDA for Lonsurf (trifluridine/tipiracil, TAS-102) as a treatment for patients with previ...
An FDA Advisory Committee delivers a mixed vote (10 to 9) in favor of continuing required cardiovascular outcomes trials for all new diabetes drugs.
Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Product Labeling; Medication Guide Requi...
Faced with resistance from the pharmaceutical industry, Health and Human Services Secretary and former Eli Lilly executive Alex Azar says that HHS is ...