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FDA Alerts

FDA Alert
FDA
FDA Alert
FDA Approves First Nonsteroidal Treatment for Patients With Duchenne Muscular Dystrophy
04/18/2024

Anthony Calabro, MA

Anthony Calabro, MA
The FDA approved givinostat, a nonsteroidal oral medication, for treating patients 6 years of age or older with Duchenne muscular dystrophy.
04/18/2024
FDA alert
test tubes
FDA alert
FDA Approves Biosimilar Treatment for Patients With Multiple Sclerosis
11/14/2023
Jessica Ganga
The FDA has approved the first biosimilar treatment for patients living with relapsing forms of multiple sclerosis.
11/14/2023
FDA Alert
fda
FDA Alert
FDA Approves First Treatment of Agitation in Patients With Alzheimer Dementia
05/15/2023
Jessica Ganga
Following two 12-week studies, the FDA has approved the first ever medication for treating agitation in patients with dementia due to Alzheimer disease.
05/15/2023
FDA ALERT
medication
FDA ALERT
FDA Approves First Treatment for Rare, Degenerative Disease
04/18/2023
Jessica Ganga
The FDA has approved a treatment for Friedreich ataxia after the results of randomized, placebo-controlled study indicate a strong effectiveness in treatment.
04/18/2023
Enzyme Replacement Therapy
Enzyme Replacement Therapy
First Enzyme Replacement Therapy to Treat Rare Genetic Disorder Approved
03/17/2023
Jessica Ganga
Following a multicenter study, the FDA has approved the first enzyme replacement therapy in the United States to treat alpha-mannosidosis.
03/17/2023
Treatment
Treatment
FDA Accelerates Approval for New Alzheimer Treatment
01/10/2023
The FDA approved a treatment that targets one of the main causes of Alzheimer disease.
01/10/2023
FDA
FDA
FDA Approves Drug for Dravet Syndrome
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
FDA Approves First Tau Pathology Drug
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
FDA Approves New Acute Treatment for Migraine With or Without Aura
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
FDA Approves New Generic for Adults With MS
12/06/2019
Three applications for the first generic capsules have been granted by the US Food and Drug Administration.
12/06/2019