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.
In the latest move in a multi-year wrangle between the FDA and Vanda Pharmaceuticals over the agency’s proposed refusal to approve a supplemental new drug application (sNDA) for Hetlioz (tasimelteon) as a treatment for jet lag, the FDA is offering Vanda a hearing — but only under specified conditions. Read More
TauRx Pharmaceuticals is claiming an Alzheimer’s win despite admitting that the study’s placebo blinding broke — and that a valid placebo-controlled trial is impossible with the drug, hydromethylthionine mesylate (HMTM). Read More
Problems with capsule weights, new equipment that hadn’t been qualified and air temperature discrepancies have resulted in a three-observation FDA Form 483 for the Fenton, Mo., plant of Mumbai-based generic drugmaker Alkem Laboratories. Read More
The FDA wants to remove Covis Pharmaceuticals’ preterm birth drug Makena (hydroxyprogesterone caproate) from the market, contending that 11 years of postmarket data have failed to show Makena actually does what Covis claims — improve neonatal outcomes in premature births. Read More
With the FDA approval in hand, Kite intends to use the facility to focus on what is considered a crucial element in the CAR T therapy development process. Read More