This article was originally published in The Gray Sheet
Atlanta, Georgia-based distributor obtains FDA approval to market its MFL5000 extracorporeal shockwave lithotripter for procedures to disintegrate middle and lower urethral stones. The device, which was approved for use in treating kidney and upper urethral stones in July 1991, can now be used to treat patients who would otherwise be treated by more invasive procedures such as endoscopic stone removal, Dornier says.
You may also be interested in...
FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.
In a surprise to the market, Dr Reddy’s and Hikma have prevailed in challenging six method-of-use patents shielding Amarin’s Vascepa in the US, opening the door for a potential at-risk launch that would likely be challenged by the originator.
Duo will study up to four novel preclinical targets identified by Sitryx that may lead to potential new drugs for autoimmune diseases, which Lilly would then commercialize.