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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
As of Wednesday night, the Federal Trade Commission (FTC) had received a whopping 24,113 comments in response to its February notice soliciting input on how pharmacy benefit manufacturer (PBM) practices affect patients and payers. Read More