After warning that casual use of testosterone meds can cause heart attack and stroke, the FDA has finally put its foot down to curb overprescribing of the drugs. But some say the agency needs to go further.
The FDA has already admitted that it made a mistake with its initial approval letter for Vanda Pharmaceuticals' sleep disorder drug early last year, a consumer advocacy group says. And now, that group is demanding the agency do a better job fixing it.
Just weeks after winning the first case to go to trial that accused Pfizer of hiding birth defect risks for the children of women who took the antidepressant Zoloft during pregnancy, the pharma giant has again convinced a jury that there was no credible connection. The results are positive for Pfizer, but the company still faces more than 1,000 lawsuits alleging similar claims.
Proton pump inhibitors, including AstraZeneca's longtime blockbuster Nexium, are some of the most commonly used drugs in the world to treat heartburn. But they may also be increasing the risk of heart attack, a new study shows.
Last month, Merck & Co. said Januvia passed its heart safety test. Now, the much-anticipated TECOS trial has had its airing at the American Diabetes Association meeting, and the study authors say the drug is in the clear.
Dermal fillers are meant to minimize the appearance of wrinkles and give the face a smoother, fuller appearance. But they may also have some nasty consequences if injected incorrectly, and so the FDA is calling for some updated labeling on the products.
A month ago, Amgen and AstraZeneca were confidently rolling up data from three highly touted late-stage studies on the psoriasis drug brodalumab for a new drug application that was widely viewed as a shoo-in at the FDA. But late Friday evening, Amgen abruptly said it was pulling out of the long-running collaboration on the high-profile IL-17 program after evaluating the likely commercial impact it would face in light of the suicidal thoughts some patients reported during the studies.
U.S. regulators gave GlaxoSmithKline's Advair the green light a decade and a half ago, paving the way for a long reign that saw the med grow to more than $8 billion in annual sales. But even after all these years, whether Advair poses a higher risk of asthma-related death remains unclear, ProPublica says.
A fund for victims of a fungal meningitis outbreak that sprung from contaminated drugs sold by the now-defunct New England Compounding Center has reached $200 million, twice what was initially expected.
On May 17, the FDA announced that it released a draft guidance that sets out rules for compounding animal drugs from bulk substances. In so doing, the FDA is recognizing that in some situations, treating animals with specially formulated versions of approved drugs would be impossible.