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CDER released a revised Manual of Policies and Procedures on expedited reviews of prior approval supplements for new drug and biologics license applications that involve chemistry, manufacturing and controls changes. Read More
The drugs will be available to any eligible patients three months after NICE publishes its final guidance. Midostaurin and brentuximab vedotin will be available at a confidential discounted price. Read More
In a 17-0 vote, the FDA’s Antimicrobial Drugs Advisory Committee voted that the data show a favorable risk-benefit profile for TPOXX (tecovirimat) for its proposed indication for treating smallpox caused by variola virus in adults and pediatric patients. Read More