A recent Health Canada inspection of the country's only flu vaccine production plant identified 10 issues that need to be addressed, a report from the regulatory agency reveals. The summary report of the June inspection said none of the problems found poses a critical risk to public health, but seven fall into the major observation category.
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.
Shire and ArmaGen announced a worldwide licensing and collaboration agreement for AGT-182, an investigational enzyme replacement therapy (ERT) for the potential treatment of both the central nervous system (CNS) and somatic manifestations in patients with Hunter syndrome (MPS II).
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.
Drug companies and medical device makers are making multi-billion-dollar merger deals to avoid high U.S. corporate taxes. How do so-called "inversion deals" work?
Health officials on Monday advised patients of a West Virginia pain management clinic to be tested for blood-borne infectious diseases after an investigation found that needles had been reused.
Scientists have linked more than 100 spots in our DNA to the risk of developing schizophrenia, casting light on the mystery of what makes the disease tick. Such work could eventually point to new treatments, although they are many years away. Already, the new results provide the first hard genetic evidence to bolster a theory connecting the immune system to the disease.
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.
A case challenging Arizona's refusal to reveal detailed information about the lethal drugs it plans to use to put an inmate to death is now headed to the U.S. Supreme Court. The dispute centers on whether a man convicted of killing his estranged girlfriend and her father has a constitutional right to know more about his execution than Arizona officials have been willing to disclose.
AstraZeneca today announced that MedImmune, its global biologics research and development arm, has entered into a clinical trial collaboration with Advaxis, Inc., a US-based biotechnology company developing cancer immunotherapies.
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.
Johnson & Johnson, the world's biggest maker of health care products, plans to buy back up to $5 billion of the company's common stock. The maker of prescription drugs, medical devices and Tylenol said Monday that its board of directors had approved the stock buyback program.
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.
Johns Hopkins Hospital has agreed to a $190 million settlement with more than 8,000 patients of a gynecologist who secretly photographed and videotaped women's bodies in the examining room with a pen-like camera he wore around his neck.