To learn how best to prescribe powerful drugs to children, Congress passed a law in the 1990s that rewarded drug makers for conducting clinical studies involving children. Among the incentives for cooperating companies was a possible six-month extension of protection from generic competition after a

The Food and Drug Administration has agreed to give priority status to its review of three new uses for the anticlotting drug Xarelto, Johnson & Johnson announced Monday.The company is asking the agency to approve the drug to treat deep vein thrombosis and pulmonary embolism, and to prevent recu

In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug, f

(Reuters) – Europe’s medicines regulator, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information.The change is a landmark in transparency that puts E

WASHINGTON — A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, jou

Wales’ health minister says it was “entirely appropriate” for her civil servants to be in contact with the author of a report into the NHS.Lesley Griffiths defended emails between senior officials and the academic behind the report.Officials were also challenged about why local health boards thought

More than 200 researchers investigating colon cancer tumors have found genetic vulnerabilities that could lead to powerful new treatments. The hope is that drugs designed to strike these weak spots will eventually stop a cancer that is now almost inevitably fatal once it has spread.Scientists increa

Two days after Debra Demidon underwent in vitro fertilization, she gained more than 30 pounds in fluid and suddenly was struggling to breathe.Doctors diagnosed severe ovarian hyperstimulation syndrome (OHSS), a complication seen in some women who undergo fertility treatment. It landed Ms. Demidon in

A drug already on the market that treats immune disorders may help stabilize patients with Alzheimer’s disease for up to three years, according to the results of a tiny study presented at a conference on Tuesday.All four patients who received the optimal dose of the drug, Gammagard from Baxter Inter

(Reuters) – An international health panel has recommended for the first time that all HIV patients be treated with antiretroviral drugs, even when the virus’s impact on their immune system is shown to be small.The nonprofit International Antiviral Society-USA cited new evidence that untreated infect