Tag: Drug Approvals
Trials Supporting FDA Approval of Breakthrough Drugs Examined
Pivotal trials supporting these approvals often lack randomization, double-blinding, control groups
FDA Approves First Drug to Treat Smallpox
New treatment offers additional option should smallpox ever be used as a bioweapon
FDA Approves First Generic Under-the-Tongue Suboxone
May only be prescribed by Drug Addiction Treatment Act-certified prescribers
FDA OKs 1st Biosimilar to Prevent Chemo-Related Infections
Fulphila, biosimilar to Neulasta, helps reduce risk of infection during cancer treatment
FDA Approves First Artificial Iris
CustomFlex Artificial Iris improves light sensitivity and glare, cosmetic appearance of the eye
FDA Approves New Treatment for Ulcerative Colitis
First oral medication approved for chronic use in moderate-to-severe active ulcerative colitis
FDA Approves Palynziq for Phenylketonuria
Drug is a novel enzyme therapy for adult patients with PKU with uncontrolled blood Phe concentrations
FDA Approves Aimovig to Prevent Migraines
Patients taking Aimovig reported one to two fewer monthly migraine days than those taking pacebo
FDA OKs Doptelet for Liver Dz Patients Undergoing Procedures
Doptelet reduces the need for platelet transfusion or any rescue therapy on day of procedure
FDA Approves Non-Opioid Treatment for Opioid Withdrawal
Lucemyra is an oral selective alpha 2-adrenergic receptor agonist
