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Attention deficit hyperactivity disorder in children and young people: guanfacine prolonged-release

RegulatorNICE2016-03-22 14:13 Read   166

Guanfacine prolonged‑release (Intuniv) is a non‑stimulant treatment for children and young people with attention deficit hyperactivity disorder (ADHD).

FDA proposes ban on most powdered medical gloves

RegulatorFDA2016-03-22 10:06 Read   78

Today, the U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States.

CDC Issues New Guidelines To Combat Opioid Epidemic

RegulatorForbes2016-03-21 16:53 Read   88

In response to the continuing epidemic of deaths from overdoses of prescription opioids, the CDC today issued new recommendations to help prevent opioid misuse and overdose, with the goal of improving patient safety and overall care.

Greg Simon Named Executive Director for the White House's Cancer Moonshot Task Force

RegulatorFriends of Cancer Research2016-03-21 14:37 Read   161

Friends of Cancer Research would like to congratulate Greg Simon on being named executive director of the White House's Cancer Moonshot Task Force.

Senate Puts Forth Legislation on FDA Centers of Excellence

Regulator Immediate Release2016-03-21 14:31 Read   76

Senator Alexander and Senator Murray for introducing the FDA and NIH Workforce Authorities Modernization Act. The Act takes several steps that will ultimately enhance cutting edge medical research. 

Medivation's mystery cancer drug gets out from an FDA hold

RegulatorMedivation2016-03-10 10:43 Read   120

Medivation ($MDVN) alarmed regulators earlier this year with the revelation that its mid-stage cancer drug, purported to block the protein PD-1, didn't do that at all, leading the FDA to put the program on hold.

Two Indian states halt sales of Roche's Avastin drug

Regulatorreuters2016-01-20 10:03 Read   203

Two Indian states have put sales of Swiss drugmaker Roche's blockbuster drug Avastin on hold, officials said on Tuesday, after it hampered the vision of 15 patients who used it for a condition it is not officially meant to treat.

U.S. FDA accepts for priority review sNDA for Eisai’s anticancer agent lenvatinib seeking approval for renal cell carcinoma

RegulatorEisai2016-01-19 11:36 Read   250

Eisai Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) submitted by its U.S. subsidiary Eisai Inc. for Eisai’s in-house developed novel anticancer agent lenvatinib mesylate (generic name, “lenvatinib”) for use in the treatment of advanced or metastatic renal cell carcinoma, and granted the sNDA Priority Review status.

FDA outlines cybersecurity recommendations for medical device manufacturers

RegulatorFDA2016-01-18 09:37 Read   766

The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health.

FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk

RegulatorFDA2016-01-18 09:27 Read   316

The U.S. Food and Drug Administration today cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model currently being used in health care facilities and make the needed repair as quickly as possible.

FDA Issues Complete Response Letter for KyndrisaTM for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

RegulatorBioMarin2016-01-15 09:14 Read   404

BioMarin Pharmaceutical Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter to the Company's New Drug Application (NDA) for KyndrisaTM (drisapersen) for the treatment of Duchenne muscular dystrophy (Duchenne) amenable to exon 51 skipping.

In a win for LivaNova, the FDA approves the world's only sutureless aortic valve

RegulatorFDA2016-01-14 14:42 Read   949

London's LivaNova ($LIVN) can now sell the only sutureless surgical aortic valve in the U.S., thanks to the FDA's PMA approval of its Perceval device. The company is hoping the device can overcome the strong trend toward implantation of transcatheter aortic valve replacements, which are procedurally (as opposed to surgically) installed using a delivery catheter and guidewire.