Articles related to DEVICE/DRUG APPROVALS

The new chemical entity is an atypical antipsychotic and the active metabolite of iloperidone (Fanapt). Its ability to cross the blood-brain barrier likely contributes to iloperidone’s clinical effects.

“Patients treated in the Optune Pax arm had a median time to pain progression of 15.2 months compared to 9.1 months.” — PANOVA-3 Trial, FDA Approval Announcement

64% of those who self-administered Cardamyst converted to sinus rhythm within 30 minutes compared with 31% who received placebo.

“People are more used to taking pills than they are taking injections” but “90% of a person’s weight is the result of what they eat. There are no magic solutions.”

“The updated label for Nexplanon reflects the diversity of patients we see every day, women throughout their reproductive ages, those seeking a long-acting option of up to 5 years, those who prefer birth control that goes in the arm rather than the uterus, and women across a wide range of BMIs,” said Anita Nelson, MD, Professor, Obstetrics and Gynecology at Western University of Health Sciences.

“We are surprised and disappointed by this FDA decision for EBV+ PTLD patients who have a significant unmet need, highlighted by tabelecleucel’s orphan drug designation and by the granting of breakthrough status.” — Dr. Cokey Nguyen, Atara CEO