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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
After getting a Complete Response Letter (CRL) from the FDA last spring due to manufacturing deficiencies, UCB Pharma says the agency has accepted its biologics license application (BLA) resubmission for bimekizumab for the treatment of adults with moderate-to-severe plaque psoriasis. Read More
As the year comes to a close, we look at some of the FDA’s noteworthy new drug approvals, including two pricey gene therapies and other advancements for treatment of neurological conditions, such as Amyotrophic Lateral Sclerosis (ALS) and other rare diseases. Read More