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FDA issues Moderna a refusal-to-file letter on its BLA for an investigational seasonal influenza vaccine mRNA-1010, despite the co...[ Price : $8.95]
FDA issues two untitled letters to Argenx, alleging that separate direct-to-consumer television advertisements for Vyvgart Hytrulo...[ Price : $8.95]
Aurobindo Pharma says that FDA has completed an inspection of wholly owned subsidiary Eugia Pharma Specialities in Pashamylaram, T...[ Price : $8.95]
FDA tells Novo Nordisk that a new direct-to-consumer television ad for the newly launched Wegovy (semaglutide) oral weight-loss pi...[ Price : $8.95]
FDA issues Regenxbio a complete response letter on its BLA seeking accelerated approval for RGX-121 (clemidsogene lanparvovec), a ...[ Price : $8.95]
The Alliance for Pharmacy Compounding petitions FDA asking that it reverse its classification of desiccated thyroid extract as a b...[ Price : $8.95]
FDA clears a Median Technologies 510(k) for eyonis LCS, the first artificial intelligencebased device cleared for both detection a...[ Price : $8.95]
FDA drug regulators and pharmaceutical industry representatives reach a partial agreement on drug development tools, including bio...