FDA Updates Clozapine REMS Program

August 2nd 2021

Pharmacies will need to obtain pre-dispense authorization for clozapine.

Piqray’s Safety Label is Updated

July 30th 2021

Some fatal cases of ketoacidosis have occurred, and high-risk patients should be monitored when starting treatment.

Ardelyx Receives Complete Response Letter for Kidney Disease Therapy

July 29th 2021

The FDA is requesting an additional study to demonstrate tenapanor lowers serum phosphorus.

Specialty Pharmacies Grapple with Assessing Costs and Value of Oncology Therapies

July 29th 2021

Drugs that provide only incremental benefit may not be included on clinical pathways.

FDA Approves First Biosimilar Insulin

July 29th 2021

The approval allows for substitution at the pharmacy counter for Lantus, its reference product.