FDA Alert
FDA Alert
01/31/2025
Kate Young
The FDA has approved suzetrigine 50 milligram oral tablets for moderate to severe acute pain in adults. The drug acts on the peripheral nervous system before pain signals can reach the brain, eliminating...
01/31/2025
FDA Alert
FDA Alert
01/29/2025
Miranda Manier, BA
The FDA has proposed new draft guidance to improve the accuracy of pulse oximeters across all skin tones, addressing long-standing concerns about potential disparities in performance.
01/29/2025
FDA Alert
FDA Alert
01/28/2025
Anthony Calabro, MA
The FDA is seeking a cap on nicotine levels in cigarettes and certain tobacco products at minimally or nonaddictive levels. This initiative, if finalized, would be what the FDA calls a “significant step”...
01/28/2025
FDA Alert
FDA Alert
01/16/2025
Miranda Manier, BA
Acoramidis, an oral therapy, is now approved to reduce cardiovascular-related deaths and hospitalizations in adults with hereditary or wild-type ATTR-CM.
01/16/2025
FDA Alert
FDA Alert
01/09/2025
Anthony Calabro, MA
The FDA has approved concizumab-mtci, a daily subcutaneous treatment to reduce bleeding for patients with hemophilia who have clotting factor inhibitors.
01/09/2025
FDA Alert
FDA Alert
01/06/2025
Anthony Calabro, MA
Crinecerfont, a first-in-class therapy, improved androgen control and reduced reliance on high-dose glucocorticoids for patients with congenital adrenal hyperplasia.
01/06/2025
FDA Alert
FDA Alert
01/01/2025
Anthony Calabro, MA
The FDA has approved tirzepatide, the first-ever drug option to treat moderate to severe obstructive sleep apnea in adults with obesity.
01/01/2025
FDA Alert
FDA Alert
09/30/2024
Miranda Manier, BA
Two randomized, double-blind studies demonstrated that a new antipsychotic treatment for adult patients with schizophrenia may lead to a meaningful reduction in symptoms.
09/30/2024
FDA Alert
FDA Alert
09/27/2024
Anthony Calabro, MA
The nasal spray is the first vaccine for the prevention of influenza that does not need to be administered by a health care provider.
09/27/2024
FDA Alert
FDA Alert
08/23/2024
Anthony Calabro, MA
The first nalmefene hydrochloride auto-injector is another emergency treatment tool to reverse known or suspected opioid overdose.
08/23/2024