Articles related to FDA

Unacceptable levels of N-nitroso atomoxetine, a potential carcinogen, were found in multiple atomoxetine batches, according to the FDA.

The FDA gave the recall a class 2 risk level, meaning that drinking the creamers ‘may cause temporary or medically reversible adverse health consequences,’ or that the possibility of serious health consequences is ‘remote.’

“…three drugs were associated with more negative or failed efficacy trials than positive ones…”

Results of multiple clinical trials demonstrate that SYMBRAVO can provide rapid and long-lasting freedom from migraine pain, whether treatment is taken early in the attack while the pain is mild, or later in the attack when the pain may be severe.

Rapid symptom improvement and sustained 4-week benefits distinguish Spravato monotherapy in treatment-resistant depression, with significant MADRS score reductions versus placebo.

The phase 3 ALLELE trial demonstrated tabelecleucel’s potential with a 50.7% overall response rate and median duration of response of 23.0 months in EBV+ PTLD patients.