FDA approved a new treatment for non-small cell lung cancer, as well as drugs to treat chronic immune thrombocytopenia and a rare form of childhood rickets.
A new draft guidance document from FDA aims to help pharmaceutical manufacturers develop new medications to treat opioid use disorder.
FDA approved a new indication for Exparel Bupivacaine Liposome injectable suspension (Exparel, Pacira) for use as a nerve block to produce post-surgical regional analgesia following shoulder surgery in adults.
FDA is permitting marketing of the first medical device that uses artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy.
After US Surgeon General Jerome M. Adams, MD, MPH, urged more Americans to carry naloxone to reverse opioid overdoses, organizations and medical experts praised the decision.
A new deal between pharma giants AbbVie and Samsung Bioepis is designed to postpone competition against a biosimilar to Humira until 2023.
FDA okayed the marketing of a new continuous glucose monitoring system for diabetics—the first to be used as part of an integrated system with other compatible medical devices and electronic interfaces.
Due to problems with compounded medications— including the 2012 fungal meningitis outbreak that led to 64 deaths—FDA is releasing a draft guidance that will determine which bulk drug substances outsourcing facilities can use to compound drugs.
FDA’s approval of a new combination treatment for patients with classical Hodgkin lymphoma (cHL) is the first new advanced treatment for the disease in 40 years
As FDA considers new guidelines on pharmaceutical product marketing, a new study found that pharma makers may not be following current FDA ad regulations.