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Avadel Specialty Pharmaceuticals called on the FDA to deny approval for certain demopressin acetate treatments for nocturia, including a pending drug application by Ferring, expressing concern over the pharmaceutical company’s clinical trial data and patent certification for the drug. Read More
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