FDA Alerts

prevention
prevention
05/18/2018
Following the success of 3 clinical trials, the US Food and Drug Administration granted approval to a once-monthly, self-injectable preventive treatment for adults with migraine.
05/18/2018
FDA
FDA
05/17/2018
The US Food and Drug Administration has granted approval to the first non-opioid treatment option for the management of withdrawal symptoms in adults who abruptly discontinue opioids.
05/17/2018
FDA
FDA
05/15/2018
The US Food and Drug Administration has approved the first biosimilar to epoetin alfa for the treatment of anemia due to various causes.
05/15/2018
FDA
FDA
05/14/2018
The US Food and Drug Administration has expanded the indication of an approved MS drug, making it the first drug approved for use in some pediatric patients with relapsing multiple sclerosis.
05/14/2018
FDA
FDA
05/09/2018
The US Food and Drug Administration has approved a supplemental new drug application for the use of a previously approved drug for the treatment of hyperkalemia which may allow for more flexibility and ease...
05/09/2018
FDA
FDA
05/09/2018
The US Food and Drug Administration has approved a supplemental new drug application for the use of a combination therapy to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and...
05/09/2018
FDA
FDA
04/25/2018
The US Food and Drug Administration has approved the first drug to slow the decline of kidney function in adults with a high risk of rapidly progressing autosomal dominant polycystic kidney disease.
04/25/2018
FDA
FDA
04/25/2018
Following the success of the IMPACT study, the US Food and Drug Administration has approved an expanded indication of a drug used to treat COPD.
04/25/2018
Epilepsy
Epilepsy
04/20/2018
Based on evidence from several clinical trials, an FDA advisory committee has voted unanimously to recommend the approval of a cannabis-based oral solution for the treatment of 2 rare forms of epilepsy. ...
04/20/2018
FDA
FDA
04/18/2018
After reviewing data from 2 randomized placebo-controlled Phase 3 trials and an open-label extension, the FDA has approved a new option for the treatment of adults with chronic immune thrombocytopenia. ...
04/18/2018