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The FDA has denied Ardelyx’s new drug application (NDA) for tenapanor as a treatment for chronic kidney disease in adults on dialysis, citing concerns over the treatment’s effectiveness. Read More
The EMA’s human medicines committee is assessing data from two clinical trials and is expected to reach a decision by October, unless more information is required. Read More
Prograf, which is the first FDA-approved immunosuppressant for this treatment group, was previously cleared to prevent organ rejection in liver, kidney and heart transplant patients. Read More
The approval includes an updated indication for patients who are ineligible for chemotherapy containing cisplatin and those who have received at least one prior line of therapy. Read More
Darzalex Faspro is the only subcutaneous anti-CD38 monoclonal antibody cleared for use with the anti-cancer regimen pomalidomide and dexamethasone. Read More
The drugmakers anticipate a significant demand for the new treatment, noting that many severe asthma cases remain uncontrolled despite the prevalence of inhaled controller medicines, oral corticosteroids and currently available biologics. Read More
The FDA has granted a Priority Review to AstraZeneca and Amgen’s investigational asthma treatment tezepelumab — setting a target decision date for the Biologics License Application (BLA) in the first quarter of 2022. Read More
Merck said it made the voluntary decision in consultation with the FDA following the evaluation of the application by the agency’s Oncologic Drugs Advisory Committee. Read More