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.
A former Eli Lilly employee is suing the drugmaker over allegations she was fired after identifying numerous production issues at Lilly’s Branchburg, N.J., plant, including in the manufacture of the company’s blockbuster, Trulicity. Read More
Johnson & Johnson (J&J) is pulling out of its COVID-19 vaccine supply contract with the troubled drug manufacturing plant, Emergent BioSolutions. Read More
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