After voting 17-1 that data from a National Institutes of Health (NIH)-sponsored animal study were sufficient to approve Amgen Inc.'s Neupogen as a treatment for radiation sickness, two FDA advisory committees told the agency that the data should be applied to all drugs in the same class.
Despite moving testimony from patients stressing the need for more options to treat advanced kidney cancer, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 13-1 Thursday against the adequacy of AVEO Oncology Inc.'s single Phase III trial to support the approval of tivozanib.
The slow pace of progress is wearing on the SEC's Advisory Committee on Small and Emerging Companies as it waits for the commission to move on recommendations it's suggested to help small companies get the capital they need to grow and create jobs.
Shares of AVEO Oncology Inc. plummeted to historic lows Tuesday with the realization that the company may have to conduct a second Phase III trial before the FDA considers approving tivozanib to treat advanced renal cell carcinoma (RCC).
Look! Up in the sky! It’s a bird! It’s a plane! It’s . . . another superbug. The invasion of the multidrug-resistant superbugs is not a nightmare in the making. It’s already here. And it could be years before a new superhero lands in Metropolis to knock out the worst of the worst of these villains that are set on world domination. In a twist on the usual comic book tale, the super-resistant strains of CRE, malaria and tuberculosis threatening the world today are not the work of a mad scientist scheming away in a remote underground lab. They are...
As advocates for Alzheimer's research swarmed Capitol Hill this week, they told lawmakers, in polite terms, to put federal funding where their mouths are.
While the development and approval of biosimilars, especially monoclonal antibodies (mAbs), are moving at a snail's pace in developed countries, the copycat drugs are racing forward in Asia and Latin America.
While the development and approval of biosimilars, especially monoclonal antibodies (mAbs), are moving at a snail's pace in developed countries, the copycat drugs are racing forward in Asia and Latin America.
Superbugs are staging a global onslaught that will only get worse with time unless a modernized arsenal is developed to stop them. But an inventory of new weapons under development doesn't look like enough is being done to turn the tide anytime soon.
