Daiichi Sankyo announced that the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily SAVAYSAT 60 mg dosing regimen for the reduction in risk of stroke and systemic embolic events in patients with non-valvular atrial fibrillation.
Fever? Headache? Muscle aches? Forget about Ebola — chances are astronomically higher that you...
Federal regulators announced Thursday they were suing Gerber, the well-known baby food maker,...
AstraZeneca today announced that the FDA has approved once-daily XIGDUO™ XR (dapagliflozin and...
Pfizer announced that the FDA has granted accelerated approval of TRUMENBA ® (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
The U.S. health care apparatus is so unprepared and short on resources to deal with the deadly Ebola virus that even small clusters of cases could overwhelm parts of the system, according to an Associated Press review of readiness at hospitals and other components of the emergency medical network.
The European Medicines Agency (EMA) has given scientific advice to GSK on its development plan for an Ebola vaccine. This is the first time in the current Ebola outbreak that EMA has given ‘rapid scientific advice’ using an accelerated procedure.
Health officials say a vaccine against Ebola could be ready in 2015.
The U.S. government is working to seize all colored contacts not approved by the FDA.
U.S. health officials are recommending that people who are at highest risk for coming down with Ebola avoid commercial travel or attending large public gatherings, even if they have no symptoms. The CDC issued the updated advice to state and local officials on Monday.
For Americans wondering why President Barack Obama hasn't forced all states to follow a single, national rule for isolating potential Ebola patients, the White House has a quick retort: Talk to the Founding Fathers.
The Swiss agency that regulates new drugs has approved an application for a clinical trial with an experimental Ebola vaccine at the Lausanne University Hospital. Swissmedic said the trial will be conducted among 120 volunteer participants with support from the U.N. World Health Organization.
Drugmakers are racing to develop vaccines and drugs to address the worst outbreak of Ebola in history. It's unclear who will pay for their products, but companies are betting that governments and aid groups will foot the bill.
The World Health Organization says millions of doses of two experimental Ebola vaccines could be ready for use in 2015 and five more experimental vaccines will start being tested in March. Still, the agency warned it's not clear whether any of these will work against the deadly virus that has...
New federal Ebola response squads — likened to public health SWAT teams — are being readied to rush to any U.S. city where a new Ebola case might be identified, officials say.
The EMA has established a form of rolling review that allows experts to continuously assess incoming data and develop increasingly robust scientific opinions based on the additional data provided during the process. The initial review and subsequent updates will be shared with healthcare decision-makers in the most affected and other countries.
Researchers at Harvard found that two-thirds of dietary supplements that have previously been recalled still contain banned ingredients. Also, smoking may get in the way of recovering alcoholics.
Most Americans have some confidence that the U.S. health care system will prevent Ebola from spreading in this country, but they're not so sure their local hospital can safely handle a patient, according to an Associated Press-GfK poll.
Vaxart, a privately held company developing vaccines that are administered by tablet rather than by injection, today announced that the company is accelerating its Ebola tablet vaccine program. Following a recent meeting with the FDA, Vaxart anticipates commencing human clinical trials in the first quarter of 2015.
Stepping up their vigilance against Ebola, federal authorities said Wednesday that everyone traveling into the U.S. from Ebola-stricken nations will be monitored for symptoms for 21 days. That includes returning American aid workers, federal health employees and journalists, as well as West African travelers.
The recent FDA approval of Harvoni, Gilead Sciences’ once-daily, single-tablet regimen to treat chronic hepatitis C virus genotype 1 infection in adults, will enable the company to maintain its dominance in an increasingly competitive market, says an analyst with research and consulting firm GlobalData.
Dietary supplements containing potentially dangerous prescription drug ingredients may still be for sale even years after safety recalls, a study found. In supplements bought online, researchers detected hidden steroids, similar ingredients to Viagra and Prozac and a weight loss drug linked with heart attacks.
Vertex announced that the FDA’s Pulmonary Allergy Drugs Advisory Committee voted 13-2 to recommend approval of KALYDECO® in people with cystic fibrosis ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory gene, which is the indication being reviewed by the FDA.
An increase in the number of prescriptions of a powerful antipsychotic drug for conditions not approved by Health Canada is raising concern about what medical experts call lack of professional and government oversight of doctors' prescribing practices.
The federal government is closing a gap in Ebola screening at airports while states from New York to Texas to California work to get hospitals and nurses ready in case another patient turns up somewhere in the U.S. with the deadly disease.
The FDA has accepted the filing of a New Drug Application for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with type 2 diabetes.
Federal officials are going on the road with new guidelines to promote head-to-toe protection for health workers treating Ebola patients. Centers for Disease Control and Prevention officials will be demonstrating the recommended techniques Tuesday at a massive training at New York City's Javits Center, with an expected attendance of thousands.
A top World Health Organization official says the hunt for an Ebola vaccine will produce data about whether they are safe by December — and they could be in experimental field use by January.
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the FDA voted 7 to 0 to support the approval of AIN457, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
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