Bristol-Myers Squibb and Pfizer, which have yet to get their blood thinner Eliquis approved in the U.S., have gotten a third regulatory nod elsewhere.
Roche has spent the past few months getting raked over the coals by critics who say the company has not offered full and complete access to Tamiflu data. So when the FDA extended the approval of the flu drug, the news came as a much-needed boost.
Alexza Pharmaceuticals ($ALXA) has won a long-sought approval for an antipsychotic drug called Adasuve from the FDA. Wasting no time, the company plans to push the inhaled med onto the U.S. market early in the first quarter of 2013.
The FDA has approved Aegerion's new drug for homozygous familial hypercholesterolemia, clearing a path to begin commercialization as the biotech comes to a major turning point.
Medtronic has sent a letter to customers warning that use of unapproved drugs with its SynchroMed pumps can more than double the rate of device failure, and the FDA has labeled the correction a Class I due to the risk of injury and death.
NPS Pharmaceuticals got a holiday present from the FDA, which on Friday approved its orphan drug Gattex (teduglutide) to treat adults with short bowel syndrome (SBS).
The FDA has stamped an approval on NPS Pharmaceuticals' Gattex for treating patients with short bowel syndrome. The approval sets the stage for the U.S. launch of the company's lead drug and adds to U.S. regulators' impressive tally of more than 30 new drug nods in 2012.
Pradaxa, the warfarin alternative from Boehringer Ingelheim, is again under fire only weeks after the FDA released information that the blood thinner was at least as safe as the drug it seeks to supplant.
Regulators in Europe have had an "aha" moment about Tredaptive.
Just hours after Merck spelled out that its one-time blockbuster hopeful Tredaptive had failed a huge late-stage study with more than 25,000 patients, the EMA stepped in to call for a quick review of a cholesterol drug that is currently being sold in several countries on the continent.