Diana Ernst, RPh

Most Recent Articles by Diana Ernst, RPh

FDA Committee Votes on Oral T1D Treatment Sotagliflozin

By Jan 18, 2019

The FDA takes the advice of the panel into consideration when making decisions, however it is not bound by their recommendations.

FDA: Important Updates to the Clozapine REMS Program

By Jan 17, 2019

Products covered under the Clozapine REMS program include Clozaril (HLS Therapeutics), Fazaclo (Jazz), and Versacloz (TruPharma), in addition to all generic versions.

FDA Panel Votes on Novel Osteoporosis Treatment Evenity

By Jan 17, 2019

In the Biologics License Application (BLA) resubmission, Amgen and UCB proposed to narrow the indication to treatment of osteoporosis in postmenopausal women at high risk of fracture.

Cabometyx Gets FDA Approval for Hepatocellular Carcinoma

By Jan 15, 2019

The approval of the HCC indication was based on data from the Phase 3 CELESTIAL trial (N=707) which randomized patients who previously received sorafenib to either Cabometyx or placebo.

Adacel Approved for Repeat Vaccination Against Tetanus, Diphtheria, Pertussis

By Jan 15, 2019

The approval was based on data from the Td537 study which included individuals 18-64 years old who had received a dose of Adacel 8-12 years prior (N=1330).

More Articles by Diana Ernst, RPh