The compounding pharmacy problems that have been so hard on patients and landed the FDA in the doghouse have been a savior for at least one company, KV Pharmaceutical, and its premature birth drug Makena.
Inconclusive data, confounding variables, as-yet-unreplicated results--they're all reasons critics have dismissed a link between incretin mimetics, a class of diabetes drugs including blockbusters Januvia and Byetta, and pancreatic cancer.
French health regulators say they'll usher Bayer's hormonal pill Diane 35 back onto the market, if top European watchdogs ratify the latest recommendations from a drug-safety body.
A study finds that common, over-the-counter pain relievers such as ibuprofen raise the risk of heart attack when taken at high doses for long periods of time.
Ranbaxy Laboratories' entanglements with the FDA and federal authorities for foisting adulterated drugs on consumers and then lying to cover it up have been an escalating story since 2008. But its felony pleas and $500 million settlement two weeks ago are serving up more consumer-level backlash than in any of the 5 years since the matter first surfaced.
The new analysis of Avandia safety data has made its debut. Verdict: The GlaxoSmithKline diabetes drug does not increase cardiovascular risk. What's that, you say? Wasn't Avandia pulled from the market in Europe and restricted in the U.S. for those very risks?
Researchers at Rutgers University have developed a delivery platform for the extended delivery of morphine for pain management that greatly diminishes the chances of abuse.
Forty-five women who had turned to Apotex for contraceptives to avoid having children are now looking to the Canadian drugmaker to help them pay for their babies, or their abortions, after they ended up pregnant.
FDA staffers found clear evidence to prove that Merck's blockbuster drug candidate suvorexant is quite effective in promoting sleep, but the internal review cites multiple safety issues for the high doses studied in clinical trials.
A federal judge in Australia has put the kibosh on a half-million-dollar settlement over ill effects of Merck's ($MRK) painkiller Vioxx, a drug that has spawned billions of dollars in litigation.