FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths
The U.S. Food and Drug Administration today announced the 2016 Naloxone App Competition, a public contest focused on developing innovative
Read MoreThe U.S. Food and Drug Administration today announced the 2016 Naloxone App Competition, a public contest focused on developing innovative
Read MoreThe U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with
Read MoreThe U.S. Food and Drug Administration today permitted marketing of a device that uses a small balloon to treat persistent
Read MoreThe U.S. Food and Drug Administration announced today it has taken action against 55 tobacco retailers by issuing the first
Read MoreThe U.S. Food and Drug Administration today approved the VisuMax Femtosecond Laser for the small incision lenticule extraction (SMILE) procedure
Read MoreThe U.S. Food and Drug Administration today announced the awarding of a total of $21.8 million to support 42 states
Read MoreThe U.S. Food and Drug Administration today allowed marketing of two Trevo clot retrieval devices as an initial therapy for
Read MoreThe U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing
Read MoreAfter an extensive review of the latest scientific evidence, the U.S. Food and Drug Administration announced today that it is
Read MoreThe U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel
Read MoreAs a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a
Read MoreMedia Deborah Kotz 301-796-5349 Consumers 888-INFO-FDA
Read MoreThe U.S. Food and Drug Administration today permitted marketing of two new devices to assess a patient’s cognitive function immediately
Read MoreThe U.S. Food and Drug Administration today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart
Read MoreThe U.S. Food and Drug Administration today issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient
Read MoreMedia Deborah Kotz 301-796-5349 Consumers 888-INFO-FDA
Read MoreThe U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products
Read MoreMedia Tara Goodin 240-402-3157 Consumers 888-INFO-FDA
Read MoreThe U.S. Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along
Read MoreThe U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance
Read MoreOn July 15, 2016, the U.S. District Court for the District of Minnesota entered a consent decree of permanent injunction
Read MoreThe U.S. Food and Drug Administration today approved the first intraocular lens (IOL) that provides cataract patients with an extended
Read MoreThe U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry
Read MoreThe U.S. Food and Drug Administration today approved the first focused ultrasound device to treat essential tremor in patients who
Read MoreThe U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC)
Read MoreThe U.S. Food and Drug Administration today approved the Roche cobas HPV Test as the first test for Human Papilloma
Read MoreIn support of the President’s Precision Medicine Initiative, the U.S. Food and Drug Administration today issued two draft guidances that,
Read MoreOn Tuesday, July 5, 2016, the U.S. District Court for the Southern District of Alabama entered a consent decree of
Read MoreThe U.S. Food and Drug Administration today approved the first fully absorbable stent to treat coronary artery disease. The Absorb
Read MoreThe U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests
Read MoreThe U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the
Read MoreMedia Sarah Peddicord 301-796-2805 Angela Stark 301-796-0397 Consumers 888-INFO-FDA
Read MoreThe U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and
Read MoreThe U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with
Read MoreThe U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction on Friday, June
Read MoreThe U.S. Food and Drug Administration today approved a new obesity treatment device that uses a surgically-placed tube to drain
Read MoreThe U.S. Food and Drug Administration today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1
Read MoreMedia Heidi Rebello 301-796-4566 Consumers 888-INFO-FDA
Read MoreThe U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action
Read MoreMedia Sandy Walsh 301-796-4669 Consumers 888-INFO-FDA
Read MoreThe U.S. District Court for the District of Kansas entered a consent decree of permanent injunction today between the United
Read MoreThe U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate
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