FDA Alerts

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
01/13/2025
Miranda Manier, BA
Plozasiran, a first-in-class RNA interference therapeutic, reduced triglycerides by 80% and lowered the risk of acute pancreatitis by 83% in patients with familial chylomicronemia syndrome (FCS), earning...
01/13/2025
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
10/25/2024
Miranda Manier, BA
The FDA has approved a novel therapy for patients with hemophilia A or B without inhibitors. Clinical trials showed it significantly reduces bleeding episodes by targeting a new protein in the blood...
10/25/2024
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
09/13/2024
Jessica Ganga
In June, following a placebo-controlled trial, the FDA approved pembrolizumab with chemotherapy to treat patients with primary advanced or recurrent endometrial carcinoma.
09/13/2024
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