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The FDA issued a warning letter to Grimann, an over-the-counter (OTC) drug manufacturer located near Mexico City, for failure to comply with drug registration and listing requirements. Read More
Novartis confirmed Monday it was the victim of a cyberattack that ended in stolen data but maintained the hackers didn’t get away with any sensitive information. Read More
In a March 30 meeting, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6-4 against recommending AMX0035 for patients with ALS. Read More
Novavax goes before FDA’s Vaccines and Related Biologics Advisory Committee this week, seeking Emergency Use Authorization of its COVID-19 vaccine. Read More
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