Camurus’ Oclaiz NDA resubmission accepted by FDA
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
The agreement responds directly to President Trump’s demands that drugmakers cut costs for US patients
INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway
Here's a development that aims to keep your blood pressure in check. Literally!
The deal aims to address long-standing imbalances in pharmaceutical trade while boosting investment and innovation on both sides of the Atlantic
Agreements mark a major victory in the President’s long-term pledge to lower prescription drug costs for Americans
Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval
Sotyktu continues to demonstrate consistent efficacy and safety across rheumatic conditions
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