At the request of the U.S. Food and Drug Administration, a federal judge from the U.S. District Court for the Central District of California today entered a consent decree of permanent injunction against Laclede, Inc. of Rancho Dominguez, California, and its president, Michael A. Pellico. Laclede is the manufacturer of Luvena Prebiotic products.

The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for previously treated patients with Waldenström’s macroglobulinemia (WM), a rare form of cancer that begins in the body’s immune system. The drug received a breakthrough therapy designation for this use.

The U.S. Food and Drug Administration announced today that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices.

The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.

U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D., today appointed Robert Califf, M.D., a recognized global leader in cardiology, clinical research, and medical economics, as FDA Deputy Commissioner for Medical Products and Tobacco.

The U.S. Food and Drug Administration today approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the United States.

The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

The U.S. Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone.

Today, the U.S. District Court of the Eastern District of Missouri sentenced Sabahhadin Akman, an owner of the Turkish firm Ozay Pharmaceuticals, to 30 months imprisonment and a $150,000 fine for smuggling counterfeit, misbranded and adulterated cancer treatment drugs into the U.S., including multiple shipments of Altuzan, the Turkish version of Avastin.

The U.S. Food and Drug Administration today approved Cosentyx (secukinumab) to treat adults with moderate-to-severe plaque psoriasis.