Recent FDA action (through April 2009) related to alglucosidase alfa, bosentan, cetuximab, doxepin, telavancin, quetiapine extended-release, oxycodone/niacin, and EUR-1073
Complete response
Priority review
Orphan drug designations
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
Read More