Amgen Looks to Expand Apremilast Plaque Psoriasis Indication
Results showed that apremilast met the primary end point achieving a statistically significant improvement in sPGA response at week 16 compared with placebo.
Results showed that apremilast met the primary end point achieving a statistically significant improvement in sPGA response at week 16 compared with placebo.
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.
According to the FDA’s safety communication, multiple factors may affect the accuracy of pulse oximeter readings, including poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish.
The NDA submission also includes data from the 44-week, open-label, long term extension of both trials.
Fewer childhood vaccines have been administered due to a decline in outpatient pediatric visits resulting from the COVID-19 pandemic.
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.
The approval was based on data from 2 multicenter, randomized, double-blind, phase 3 trials (ClinicalTrials.gov: NCT03285477 [N=351] and NCT03285490 [N=351]) that compared the efficacy and safety of Klisyri ointment to placebo in adults with AK on the face or scalp.
The designation is supported by data from a randomized, double-blind, placebo-controlled phase 2b study that compared gusacitinib to placebo in 97 adult patients with moderate to severe chronic hand eczema.
AZD1222 utilizes a replication-deficient chimpanzee adenovirus to deliver a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein to induce a protective immune response.
Results showed the median OS was 21.4 months in the pembrolizumab plus ipilimumab arm compared with 21.9 months in the pembrolizumab monotherapy arm.