Agency says a removable cap will lower the risk of antibiotic resistant infections but some experts see it as a modest step in curbing the sort of deadly outbreaks that occurred a few years ago.
Following a KHN investigation, the Food and Drug Administration has moved to speed up approvals of “orphan drugs” while closing a loophole that allowed drugmakers to skip pediatric testing.
In a head-to-head comparison, several of the cheaper devices performed nearly as well as the expensive hearing aids. The study lends credence to lawmakers’ efforts to get the FDA to set standards for over-the-counter versions.
Innate Immunotherapeutics, whose largest shareholder is Buffalo-area Rep. Chris Collins, received FDA approval to begin U.S. trials of its drug for treating advanced multiple sclerosis.
More than 70 drugs approved from 2001 through 2010 ran into safety concerns later that resulted in withdrawals from the market, “black box” warnings or other actions.
Even as drug pricing issues continue to draw scrutiny, federal safety regulations and incentives offer drug companies a new avenue to get a sweet return on their development costs.
Casi todos los estadounidenses con marcapasos -y personas en todo el mundo- caminan portando partes fabricadas en Tijuana, México, en donde se ha creado una industria que podría estar en riesgo si la administración Trump cambia el juego del comercio global.
The medical supply industry makes a particularly revelatory case study of the difficulties of untangling global trade.
With high-level connections in the Capitol, Parker “Pete” Petit aims to resolve regulatory issues that have haunted his wound care company.
Sen. Bernie Sanders’ bill to allow Americans to buy cheaper medicines from Canada would bypass a requirement that blocked past legislative efforts over two decades.
Marathon, maker of an expensive treatment for Duchenne muscular dystrophy, sells the drug for $140 million in cash and stock to PTC Therapeutics.
The numbers show that President Trump’s choice for FDA commissioner, Scott Gottlieb, has long-standing ties to pharmaceutical companies as a board member or consultant and that he had to recuse himself multiple times while working at the FDA.
Amid an uproar over high drug prices, three GOP senators are asking the Government Accountability Office to investigate whether the Orphan Drug Act is being abused.
More than 30 states have laws on the books to allow dying patients the right to try experimental treatments. But these treatments may not be covered by insurance, and ethicists worry vulnerable people could be exploited near the end of their lives. The laws may also duplicate a process the FDA already has in place.
Former FDA Commissioner Dr. Robert Califf shares his views about drug approvals, regulations and safety concerns after stepping down from the giant agency.
La planificación familiar, Planned Parenthood y hasta el consumo de tabaco podrían verse rápidamente afectados por medidas que podría tomar el flamante secretario de Salud.
Citing a Kaiser Health News investigation, Senate Judiciary Committee Chairman Chuck Grassley vows to examine the orphan drug program and possible fixes.
After a tough fight by Democrats, Senate Republicans confirmed Rep. Tom Price’s nomination to head the Department of Health and Human Services. He will have the authority to upend some current practices.
Una investigación de Kaiser Health News analiza las acciones de compañias farmacéuticas para manipular los precios de medicamentos huérfanos, utilizados para tratar enfermedades raras.
Drugmakers have brought almost 450 orphan drugs to market and collected rich incentives but nearly a third of those products aren’t new or were repurposed multiple times, an investigation shows.