The FDA has approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-...
The agency says FDA inspectors recently uncovered unsanitary conditions at Unique...
Regulators approved the drug for patients with forms of chronic lymphocytic leukemia, follicular...
The candidate drug, developed by the research of Dompe, has been designated as an orphan drug for the treatment of neurotrophic keratitis, a degenerative corneal disease that affects less than 1 in 5,000 people and is currently without a cure.
Eagle Pharmaceuticals today announced that the FDA has approved Ryanodex® (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures.
The medical alert came after an Ohio teen died from a caffeine overdose days before his high school graduation.
Sanofi Pasteur Begins Shipping Seasonal Influenza Vaccine for Upcoming 2014-2015 Season in United StatesJuly 22, 2014 9:04 am | News | Comments
Sanofi Pasteur, the vaccines division of Sanofi, announced today that the first lots of Fluzone (Influenza Vaccine) for the 2014-2015 influenza season have been released by the U.S. Food and Drug Administration (FDA) for distribution.
The FDA can't use an advisory panel's 2011 report on menthol cigarettes because its members had conflicts of interest, a federal judge ruled Monday. While the agency has since conducted an independent review on the public health impact of menthol cigarettes, the ruling could hinder the FDA's ability to defend any future regulation of the minty smokes.
Genentech, a member of the Roche Group, today announced that the FDA has accepted the company's supplemental Biologics License Application and granted Priority Review for Avastin® plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.
In an ideal world, OpenFDA could usher in a world of new and improved tools and products that would improve patient safety and adherence, increase physician awareness of drug safety dangers, assist healthcare decision makers who are driving prescribing behavior with better decision support, and lower the overall cost of care by reducing avoidable side effects. But we don’t live in an ideal world.
The Food and Drug Administration said Friday that it's investigating caffeine powder and will consider taking regulatory action. The agency cautioned parents that young people could be drawn to it. Caffeine powder is sold as a dietary supplement, so it's not subject to the same federal regulations as certain caffeinated foods.
The Oregon lawsuit filed Thursday in Portland contends 5-Hour Energy falsely claims customers get extra energy and focus from a unique blend of ingredients, when the boost actually comes from a concentrated dose of caffeine.
Aduro BioTech Receives FDA Breakthrough Therapy Designation for Innovative Pancreatic Cancer Combination ImmunotherapyJuly 21, 2014 8:28 am | News | Comments
Aduro BioTech, Inc., a clinical-stage biotechnology company, today announced that the FDA has granted Breakthrough Therapy Designation for its pancreatic cancer combination treatment that consists of its CRS-207 and GVAX Pancreas immunotherapies.
Regulus Receives FDA Orphan Drug Designation for RG-012, a microRNA Therapeutic for the Treatment of Alport SyndromeJuly 21, 2014 8:07 am | News | Comments
Regulus Therapeutics Inc., announced today that the FDA has granted orphan drug designation to RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21, as a therapeutic for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy.
The FDA has approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
FDA officials said Wednesday the undocumented collection contained 327 carefully packaged vials, listing pathogens like dengue, influenza and rickettsia. Last week the government only disclosed that it had recovered six glass vials of smallpox dating from the 1950s.
This draft guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent.
Purdue Pharma announced that the FDA has approved a new 7.5 mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans will now be available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour.
Medivir AB announced that the FDA has assigned a Priority Review designation to the supplemental New Drug Application for the use of once-daily Olysio (simeprevir) in combination with sofosbuvir for 12 weeks treatment of adult patients with genotype 1 chronic hepatitis C.
A Kentucky company headed by a recognized expert in nasal delivery of medication says its intranasal naloxone spray, a drug designed to treat opioid overdoses, has received Fast Track designation from the Food and Drug Administration (FDA).
Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.
Federal health advisers say there is little to no evidence that a popular technique for removing fibroids can be performed without the risk of spreading undetected cancers to other parts of the body.
QRxPharma Limited today provided feedback on its July 9th End-of-Review (EOR) meeting with the United States Food and Drug Administration (FDA). The meeting was held to discuss the feasibility and requirements for approving Moxduo.
Bad reactions to psychiatric drugs result in nearly 90,000 emergency room visits each year by U.S. adults, with anti-anxiety medicines and sedatives among the most common culprits, a study suggests.
Bristol-Myers Squibb Company today announced that, following discussions with the FDA, the company is planning a third quarter submission of a Biologics Licensing Application (BLA) for Opdivo® (nivolumab) for previously treated advanced melanoma.
Review of ADHD Drug Approvals Highlights Gaps between Pediatric Approval Process and Long-Term Safety AssessmentJuly 9, 2014 2:14 pm | News | Comments
Over the last 60 years, the FDA approved 20 medications for attention deficit/hyperactivity disorder (ADHD) based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers at Boston Children's Hospital report today in PLOS ONE.
Consumer Reports advises parents to avoid spray sunscreens for their kids while the FDA investigates potential risks.
Government workers cleaning out an old storage room at a research center near Washington made a startling discovery last week — decades-old vials of smallpox packed away and forgotten in a cardboard box.
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