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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
The FDA has accepted Harm Reduction Therapeutics’ (HRT) new drug application (NDA) for RiVive, an investigational over-the-counter (OTC) nasal spray containing 3 mg of naloxone, and has granted the compound a priority review. Read More
In a low-key pre-holiday move, the FDA converted three alternative dosing regimens of Merck’s blockbuster cancer drug Keytruda from accelerated to full approval, a move that is not likely to be questioned by critics of the accelerated approval pathway due to the wealth of safety data behind the drug. Read More