Tag:
FDA
Latest Headlines
Latest Headlines
J&J's Invokana fends off new SGLT2 rivals to hit $278M in Q1
Johnson & Johnson's SGLT2 inhibitor Invokana (canagliflozin)--among a handful of drugs in the new category of DPP-4 drugs for diabetes--not only took a big jump in sales for the first quarter but also made some significant market-share gains.
Takeda, AstraZeneca diabetes drugs need warnings on heart risk, FDA says
Diabetes drugs of Takeda Pharmaceutical and AstraZeneca should be labeled at risk of heart failure associated with them, a group of U.S. FDA advisers recommended. Nearly all of the members of an advisory panel voted for the added safety information on labels.
Smoke and mirrors on visas to increase U.S. FDA inspectors in China, WSJ says
Remember all the post-heparin-scare hoopla about the U.S. FDA increasing the number of inspectors on the ground in China to 26? Seven years later, it still has only three drug inspectors working full time and two temporarily, the total down from 8 last year, the Wall Street Journal reports.
IDT Australia release on FDA nod for 23 generics begs the question: Where's the beef?
Australia Stock Exchange-listed IDT Australia has issued another in a series of announcements about acquiring 23 generic drugs marketed in the United States, the latest release stating the U.S. FDA has noted the transfer of ownership to IDT.
FDA clears patient monitoring device focused on IVs
ivWatch announced the FDA's clearance of its namesake product to continuously monitor peripheral IVs for adverse events like infiltration of IV fluids into the surrounding skin and the leakage of medications from the tubes.
FDA announces LuSys Labs' recall of its unapproved Ebola diagnostic
The FDA cracked down on San Diego's LuSys Laboratories for selling an unapproved diagnostic for Ebola. It announced that the company recalled all 2,000+ units of its Ebola Virus One Step Test Kits in March and destroyed any remaining kits. It deemed the recall Class I, meaning exposure to the violative "product will cause serious adverse health consequences or death."
Study says no good has come from FDA's action on gout drug colchicine
A stink was raised a few years back when the FDA asked for a safety study of colchicine, an inexpensive drug that had been prescribed for decades for gout, then granted exclusive approval to one company who stepped up. As soon as the approval was in place, the price of the drug went up from pennies per pill to $5 and patients and doctors screamed foul. Now some researchers have looked into the unintended consequences of that action and found the agency made things worse for patients with the painful condition, with no benefit.
Report: Demise of NeuroControl a cautionary tale of 'Orphan Markets' for devicemakers
The demise of the company that made the Freehand system created a group of about 250 disbanded patients, and is a cautionary tale for patients, doctors and the industry about devices for rare medical conditions.
UPDATED: FDA finalizes accelerated approval pathway for critical devices, aims to get med tech to market faster
Almost a year after its proposal, the FDA finalized plans for an accelerated review program for critical medical devices and said it will begin accepting applications to participate in the new pathway on April 15.
FDA recalls fall more than 50% in Q1 2015 after reaching record high in 2014
There were 426 medical device recalls in the first quarter of this year, according to FDA's recall database, down from a record high of 968 in Q4 2014.
