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The U.S. government urges the Supreme Court to take up a patent-infringement dispute to decide whether generic drugmakers may face...[ Price : $8.95]
Researchers say that the enhanced FDA regulatory authority from the 2017 FDA Amendments Act did not significantly change the time ...[ Price : $8.95]
The Washington Legal Foundation cautions that the Trump administrations ongoing crackdown on direct-to-consumer pharmaceutical adv...[ Price : $8.95]
FDA approves Italian non-profit Fondazione Telethons BLA for Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskot...[ Price : $8.95]
Childrens Health Defense asks FDA to revoke BLA approvals for all Pfizer and Moderna mRNA Covid-19 vaccines, claiming they do not ...[ Price : $8.95]
CDER issues a Manual of Policies and Procedures for when a reference-listed drug switches from prescription to nonprescription mar...[ Price : $8.95]
FDA qualifies its first artificial intelligence drug development tool, which will be used in metabolic dysfunction-associated stea...[ Price : $8.95]
FDA posts a final guidance entitled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Prod...