uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease ~ U.S. Food and Drug Administration (FDA) agrees that data from ongoing Phase I/II studies compared to a natural history external control may serve as the primary basis for a Biologics License...

HOOKIPA Pharma Announces Pivotal Phase 2/3 Trial Design for HB-200 in Combination with Pembrolizumab Phase 2/3 pivotal trial design and protocol for HB-200 in combination with pembrolizumab for the first-line treatment of patients with HPV16+ recurrent or metastatic OPSCC aligned with FDA feedback ...

Travere Therapeutics Announces FDA Accelerated Approval of FILSPARI™ (sparsentan), the First and Only Non-immunosuppressive Therapy for the Reduction of Proteinuria in IgA Nephropathy First single molecule Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved for use in patients withIgA nephropathy (IgAN)Interim results from the ongoing Phase 3 PROTECT head-to-head trial...

Nuvilex, Inc. Applying for Orphan Drug Status to Market Pancreatic Cancer Treatment Without Competition NEW YORK, NY--(Marketwired - Apr 22, 2014) - When Nuvilex, Inc. (OTCQB: NVLX) named Clinical Network Services (CNS) as the Contract Research Organization (CRO) for its late phase clinical trials in...