FDA Alerts

FDA
FDA
06/26/2020
The FDA has approved a drug therapy to treat seizures associated with Dravet syndrome–a chronic, rare, and life-threatening form of epilepsy–among patients aged 2 years or older.
06/26/2020
FDA
FDA
05/29/2020
The FDA has granted a landmark approval to an intravenous injection for the imaging of tau pathology among patients with cognitive impairment being evaluated for Alzheimer disease.
05/29/2020
FDA
FDA
12/26/2019
It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.
12/26/2019
FDA
FDA
12/06/2019
Three applications for the first generic capsules have been granted by the US Food and Drug Administration.
12/06/2019
FDA
FDA
11/22/2019
This approval comes after the drug was found to be safe and effective in 2 randomized, double-blind, placebo-controlled trials including 655 adults with partial-onset seizures.
11/22/2019
FDA
FDA
06/05/2019
After a clinical trial showed the treatment was more effective than placebo, the FDA approved the first treatment for episodic cluster headache in adults that reduces the frequency of attacks.
06/05/2019
Seizure
Seizure
01/11/2019
The medication is to be used as an adjunctive therapy in adult and pediatric patients with complex partial seizures.
01/11/2019
Multiple Sclerosis
Multiple Sclerosis
11/26/2018
The FDA has released a warning about the potential for an increase in disability in patients with multiple sclerosis who stop taking this immunosuppressant.
11/26/2018
Migraine
Migraine
10/01/2018
The new humanized monoclonal antibody acts by reducing the effect of CGRP, which is believed to have a physiologic role in migraine.
10/01/2018
Migraine
Migraine
09/17/2018
The FDA has approved a new migraine injection available in weekly and monthly dosing options.
09/17/2018