Fezolinetant Reduces Vasomotor Symptoms Associated With Menopause
Fezolinetant is designed to reduce the frequency and severity of VMS associated with menopause by inhibiting neurokinin B binding on the kisspeptin/neurokinin/dynorphin neuron.
Fezolinetant is designed to reduce the frequency and severity of VMS associated with menopause by inhibiting neurokinin B binding on the kisspeptin/neurokinin/dynorphin neuron.
Previously, the labeling stated that the undiluted vials must be stored in an ultra-low temperature freezer.
TicoVac is an inactivated whole virus vaccine developed using a master ‘seed’ virus that is similar to the tick-borne encephalitis virus found in nature.
Fewer childhood vaccines have been administered due to a decline in outpatient pediatric visits resulting from the COVID-19 pandemic.
The approval was based on data from an open-label, single-arm study that evaluated the efficacy and safety of Nerivio in patients aged 12 to 17 years with migraine.
The approval of Cabenuva was based on data from two phase 3 trials which included 1182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) prior to initiation.
The sNDA is supported by data from the phase 3 EMPEROR-Reduced trial which compared the efficacy and safety of empagliflozin to placebo, in addition to recommended therapy, in 3730 patients with chronic heart failure with reduced ejection fraction.
Risankizumab is currently FDA-approved under the brand name Skyrizi for the treatment of moderate to severe plaque psoriasis.
In 2018, the FDA granted accelerated approval to Opdivo for SCLC based on data from the phase 1/2 CheckMate -032 trial.
A total of 131 cases of COVID-19 were reported in the interim analysis, with no hospitalizations or severe cases noted in participants who received the vaccine.