We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
While FDA’s CDER breakthrough therapy designations for new drug products have taken off dramatically, CBER has been a lot more conservative in approving applications for the new designation. Read More
The FDA does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing earlier this month that outlines how it intends to approach one contentious issue involving compounders. Read More
The FDA’s new breakthrough therapy designation has exploded in popularity, the agency says. As of Nov. 22, 108 requests for breakthrough designation have been submitted. Read More
The FDA will allow Ariad Pharmaceuticals to resume U.S. sales of its leukemia drug Iclusig, but the drugmaker must now implement a host of stringent safety measures designed to address the drug’s risk of blood clots. Read More
Amarin has received an FDA untitled letter for omitting risk information in a print promotion for its fish oil drug Vascepa, adding to a pileup of setbacks for the product. Read More
Alimera Sciences’ negotiations with the FDA on Iluvien have put the diabetic macular edema drug on a glide path to potential approval — a startling about-face following three complete response letters (CRL) for the drug’s application. Read More
Gilead Sciences’ drug Sovaldi appears primed to dominate the hepatitis C market with the release of new Phase III trial data showing subjects with genotype 1 of the virus benefit from the drug, without coupling it with interferon. Read More
The FDA has denied Public Citizen’s petition to withdraw prescription weight loss drug Xenical and its OTC equivalent Alli from the market, disagreeing with the government watchdog’s concerns that the products cause severe liver damage and offer few benefits. Read More
The FDA is bringing the citizen petition process into the 21st century by allowing for electronic submissions, the agency says in a Federal Register notice published today. Read More