Diana Ernst

1 week ago | dermatologyadvisor.com | Diana Ernst

The Food and Drug Administration (FDA) has approved Zoryve® (roflumilast) topical foam, 0.3% for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients aged 12 years and older. Zoryve foam contains roflumilast, a phosphodiesterase type 4 inhibitor. The approval was supported by data from 2 randomized, double-blind, vehicle-controlled trials that included 736 patients aged 12 years and older with mild to severe plaque psoriasis of the scalp and body.

1 week ago | endocrinologyadvisor.com | Diana Ernst

The Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) for the treatment of patients with diabetic retinopathy who have previously responded to at least 2 intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor medication. Susvimo is indicated for intravitreal use via the Susvimo ocular implant. The implant is surgically inserted during a one-time outpatient procedure and provides continuous release of ranibizumab, a VEGF inhibitor.

1 week ago | empr.com | Diana Ernst

The Food and Drug Administration (FDA) has approved Khindivi™ (hydrocortisone) oral solution as a replacement therapy in pediatric patients aged 5 years and older with adrenocortical insufficiency. Khindivi is a ready-to-use liquid formulation of hydrocortisone, developed to improve dosing accuracy and provide another option for patients unable to swallow tablets or who have special administration needs.

1 week ago | empr.com | Diana Ernst

The Food and Drug Administration (FDA) has approved Tryptyr® (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of dry eye disease. The active ingredient in Tryptyr is acoltremon, an agonist of transient receptor potential melastatin 8 (TRPM8) thermoreceptors. While its exact mechanism of action in dry eye disease is unknown, it is believed that TRPM8 thermoreceptor stimulation activates trigeminal nerve signaling, resulting in basal tear production.

1 week ago | empr.com | Diana Ernst

The Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for sevabertinib (BAY 2927088), an oral tyrosine kinase inhibitor, for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptors 2 (HER2) mutations and who have received a prior systemic therapy.