Covidien won U,S. FDA 510(k) clearance and a CE mark for a combination laparoscopic surgical device.
GlaxoSmithKline has another chance to wrangle with AbbVie over HIV drug prices. A federal appeals court ordered a new trial for GSK, which had sued Abbott Laboratories for jacking up the price of its AIDS treatment Norvir, because Abbott excluded a gay man from the jury.
Impressed by the success of the FDA's breakthrough therapy designation, U.K. regulators are considering a similar effort to speed the path for promising drugs.
A continued decline in venture capital may be hampering the advance of medical device startups, but the absence of new insurance reimbursement codes is becoming a far bigger issue.
Some researchers at Yale want the world to know that there is no firm FDA standard for proving whether a drug is safe and effective--and they see that as a serious problem that needs to be addressed.
The FDA's premarket approval process for first-time products worked at a sluggish pace through much of 2013. But there are still some noteworthy med tech devices and tests that made it though the regulatory bureaucracy.
The FDA is warning healthcare providers that there is a shortage of saline solution, as well as other IV solutions. The agency says it is working with Baxter International--which recently had to recall four lots of saline--Hospira and Braun to boost production.
Amarin's hopes of expanding the label for its omega-3 pill look even bleaker as the FDA has denied the company's appeal to reconsider its clinical data, sending shares down another 25% in premarket trading Tuesday.
The FDA said Friday that Mentholatum is recalling a variety of over-the-counter eye drops after a review of manufacturing facilities raised questions of sterility. In another sign of the globalization issues facing the FDA, the drops being recalled were manufactured in Vietnam.
Researchers have blamed the rising incidence of whooping cough in recent decades on a myriad of factors, from the weaknesses of acellular vaccines to parents' decisions to delay immunizations. Fully reversing the trend will likely involve multiple factors too, but lawmakers could begin the process with one action--tightening rules on nonmedical exemptions from vaccinations.