A Clinical Trial Vanguard online post makes the case for further FDA guidance so drug trial sponsors can successfully incorporate artificial intellige...
A federal court sentences Purdue Pharma to pay more than $5 billion in criminal penalties for its role in the U.S. opioid epidemic.
FDA medical reviewers ask the Oncologic Drugs Advisory Committee to consider their concerns about the benefit-risk assessment of AstraZenecas breast c...
FDA cites significant manufacturing and quality control concerns at a Celgene cell therapy facility in New Jersey, including deficiencies in sterile p...
FDA accepts for priority review a GSK NDA for its investigational hepatitis B treatment bepirovirsen.
Insulet recalls (Class 1) certain insulin pump components, warning that continued use could result in severe injury or death.
FDA releases the form FDA-483 with eight observations from an inspection at the Fujifilm Diosynth Biotechnologies Texas drug manufacturing facility in...
FDA warns Franklin, TN-based Lexia LLC about CGMP violations in its production of over-the-counter drugs and cosmetic products
