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.
The company will continue to work with the FDA to complete the review of the BLA and will be “ready to launch upon approval,” said TG Therapeutics CEO Michael S. Weiss. Read More
The companies said they are “assessing the FDA’s comments” in the Complete Response Letter and considering what they will need to gain approval for the indication. Read More
Pfizer and BioNTech hit back against Alnylam Pharmaceuticals’ claims alleging their COVID-19 vaccine infringed on Alnylam’s patent for lipid-nanoparticle delivery (LNP) technology. Read More
Nephron Pharmaceuticals of South Carolina has issued a voluntary recall of about 2 million doses of its medicines after an FDA inspection found a “lack of assurance of sterility” across 20 of the company’s mostly injectable medicines manufactured at its West Columbia, S.C., compounding facility. Read More
Bristol Myers Squibb’s blockbuster checkpoint inhibitor Opdivo (nivolumab) snagged approvals for two more indications as add-on therapy for unresectable or metastatic esophageal squamous-cell carcinoma. Read More
Eight years after it shelved darapladib, GSK has sold the failed cardiovascular drug to startup SciNeuro Pharmaceuticals as a potential treatment for Alzheimer’s-associated cognitive decline. Read More
Regeneron Pharmaceuticals announced that it will acquire Sanofi’s stake in the Regeneron- Sanofi collaboration on the cancer drug Libtayo (cemiplimab) for $900 million up front, 11 percent royalties on worldwide sales and other milestone payments. Read More