FDA Alerts

FDA
FDA
07/06/2020
The FDA has approved a treatment option for adults with multidrug resistant HIV infection, marking a “new class of antiretroviral medications” for this patient population.
07/06/2020
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
06/23/2020
The FDA has approved an implantable neurostimulation system designed for the treatment of intractable chronic low back pain associated with multifidus muscle dysfunction.
06/23/2020
Pediatrics
Pediatrics
06/17/2020
The US Food and Drug Administration has approved the marketing of the first video game-based digital therapeutic device for the treatment of children aged 8 to 12 years with attention deficit hyperactivity...
06/17/2020
Treatment
Treatment
06/17/2020
The drug was given priority review status by the FDA and was approved to treat adults with the rare, severe autoimmune disease.
06/17/2020
FDA
FDA
06/15/2020
The US Food and Drug Administration approved a drug for the treatment of HIV-1 infection in conjunction with other antiretroviral therapies among children aged at least 4 weeks who weigh at least 3 kg. ...
06/15/2020
Pneumonia
Pneumonia
06/05/2020
It is a new indication for the medication, which had already been FDA-approved for the treatment of patients with complicated UTIs and complicated intraabdominal infections who have limited or no...
06/05/2020
Gynecology
Gynecology
06/01/2020
The FDA has approved a new option for the treatment of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
06/01/2020
Coronary Artery Disease
Coronary Artery Disease
06/01/2020
The approval offers a new therapeutic option to decrease the risk of first myocardial infarction and stroke among patients with coronary artery disease at high risk for such events.
06/01/2020
new medications
new medications
05/29/2020
The approval comes after results from 2 phase 3 trials showed that the medication significantly reduced the amount of heavy bleeding compared with placebo.
05/29/2020