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.
More than half of the new drugs the FDA approved in 2022 were aimed at rare diseases, according to the Center for Drug Evaluation and Research’s (CDER) just-released New Drug Therapy Approvals report. Read More
On the heels of nabbing accelerated approval of its Alzheimer’s therapy Leqembi (lecanemab), Eisai has filed for full approval of the drug in patients with mild cognitive impairment (MCI) or mild dementia and confirmed presence of amyloid beta plaque in the brain. Read More
Eisai’s antiamyloid antibody lecanemab has won FDA Accelerated Approval for treatment of Alzheimer’s disease (AD) and, under the trade name Leqembi, will be available the week of Jan. 23. Read More
While we are disappointed in FDA’s decision to extend the review of our NDA, we are confident we are on the path to generating the data requested,” the company said. Read More
The FDA has extended its review of Phathom Pharmaceuticals’ new drug application (NDA) for vonoprazan, an acid-blocking drug used to treat erosive esophagitis, a severe form of acid reflux that damages the lining of the esophagus. Read More
Intercept Pharmaceuticals has resubmitted its new drug application (NDA) for obeticholic acid (OCA) for the treatment of patients with pre-cirrhotic liver fibrosis secondary to nonalcoholic steatohepatitis (NASH). Read More