Steve Duffy

Digital Content Editor

Most Recent Articles by Steve Duffy

Antibody-Drug Conjugate Gets Priority Review for Metastatic Triple-Negative Breast Cancer

By Jul 18, 2018

The FDA has set a Prescription Drug User Fee Act date of January 18, 2019 for the treatment.

FDA Outlines Plan for Increasing Nonprescription Drug Availability

By Jul 17, 2018

The draft guidance, Innovative Approaches for Nonprescription Drug Products, applies to drugs under the New Drug Application (NDA) process and "is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription," said Gottlieb in a press statement.

Canagliflozin Trial for T2D With CKD Stopped Early Due to Positive Results

By Jul 17, 2018

A clinical trial assessing canagliflozin (Invokana; Janssen) as an addition to standard-of-care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) has been stopped early after meeting its pre-specified efficacy criteria.

FDA: Scammers Sending Fake Warning Letters to Consumers

By Jul 13, 2018

"Consumers who aren't involved in manufacturing or distributing FDA regulated products should be on alert that if you get an FDA warning letter, it's probably fake, and probably a scam," said Gottlieb.

New Romosozumab BLA Includes Data from Additional Osteoporosis Trials

By Jul 13, 2018

Evenity is a bone-forming monoclonal antibody designed to inhibit the activity of sclerostin, which allows the drug to rapidly increase bone formation and reduce bone resorption simultaneously.

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