The National Institutes of Health is pressing ahead with plans to gather genetic information on 1 million Americans under President Barack Obama's Precision Medicine Initiative, angling to kick off the ambitious project next year.
For years, Pfizer has shrugged off claims that its antidepressant Zoloft causes heart defects in newborns, fighting a raft of litigation alleging that the company did not adequately warn pregnant women taking the med about its potential risks. Now the FDA is weighing in on the issue, asking the company to acknowledge some studies that link Zoloft to heart defects in babies.
India tops the world in the number of antibiotic medications used annually, leading to renewed concerns of a surge in antibiotic resistance, according to a report released by the Washington-based Center for Disease Dynamics, Economics & Policy.
Clinical trial results for well-known blood pressure drug ramipril that were published in major journals contained fabricated data, a high-profile Australian scientist has admitted, according to the BBC.
On Thursday, Allergan snagged FDA approval for a sort-of-new antipsychotic, Vraylar, to treat schizophrenia and bipolar disorder in adults. But after about a two-year delay in which a raft of antipsychotics--both generic and branded--have made it to market, the question is where it will find a place of its own.
Partners Allergan and Gedeon Richter convinced a once-skeptical FDA to clear the antipsychotic drug cariprazine on a second pass, winning approval to treat schizophrenia and bipolar disorder.
The FDA is raising red flags about bronchoscope devices used in throat or airway procedures, pointing to infections linked to products that are not cleaned properly.
The middle class in emerging market countries wants diagnostics--and Minneapolis, MN-based Ativa Medical plans to bring it to them via a point-of-care, micro lab designed for the physician office. The startup has secured a $15 million Series B round that's intended to support gaining FDA approval for its micro lab and preparing for commercial launch.
Celgene's Abraxane can't catch a break in England. Soon after losing coverage for pancreatic cancer on the country's dedicated Cancer Drugs Fund, the treatment got another thumbs-down from its official cost-effectiveness watchdogs.
The Chinese half of a Pfizer joint venture has found itself crosswise with the FDA, which has banned products from one of its plants and written it up in warning letter.