FDA Accepts UroGen’s NDA for UGN-102, Potential First Treatment for LG-IR-NMIBC
UroGen Pharma Ltd., a biotech company developing and commercializing innovative solutions for urothelial and specialty cancers, has announced the FDA acceptance of the New Drug Application (NDA) for U ...
FDA Grants Fast Track Designation to Valneva and LimmaTech’s Shigella4V Vaccine
Valneva SE, a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech firm focused on preventing life-threatening diseases, have announced that the U.S. Food and Drug Administr ...
European Commission Grants Orphan Designation to Theriva Biologics’ VCN-01 for Retinoblastoma
Theriva Biologics, a clinical-stage biotech company developing cancer therapeutics, announced that the European Commission has adopted the EMA's recommendation to grant orphan medicinal product design ...
Positive Phase 3 Results for Jazz Pharmaceuticals’ Zepzelca and Tecentriq Combo in ES-SCLC Treatment
Jazz Pharmaceuticals plc has announced positive top-line results from the Phase 3 clinical trial evaluating Zepzelca® (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Tecentriq®) ...
FDA Grants Fast Track Designation to Lantern Pharma’s AI-Enhanced Drug LP-184 for Glioblastoma
Lantern Pharma Inc., an AI company pioneering cancer therapies, announces that the FDA has granted Fast Track Designation for its investigational drug, LP-184, to treat Glioblastoma. Currently in a Ph ...
Nanoscope Therapeutics Prepares BLA Submission for MCO-010 in Retinitis Pigmentosa Following FDA Meeting
Nanoscope Therapeutics Inc., a late-stage clinical biotechnology company dedicated to developing gene therapies for retinal degenerative diseases, has announced a successful FDA meeting for its clinic ...
FDA Grants Rare Pediatric Disease Designation to Papillon Therapeutics’ PPL-001 for Friedreich’s Ataxia
Papillon Therapeutics Inc., a clinical-stage biotechnology company focused on developing multi-systemic genetic medicines to address the root causes of inherited diseases, has announced that the U.S. ...
FDA Grants Orphan Drug Designation to Immuneering’s IMM-1-104 for Pancreatic Cancer Treatment
Immuneering Corporation, a clinical-stage oncology company focused on developing universal RAS/RAF medicines for a broad range of cancer patients, has announced that the U.S. Food and Drug Administrat ...
Pfizer’s HYMPAVZI Gains FDA Nod for Hemophilia A and B Without Inhibitors
Pfizer Inc. announced the FDA approval of HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis aimed at preventing or reducing the frequency of bleeding episodes. This approval covers both adult and p ...
FDA Approves Accord BioPharma’s IMULDOSA for Treating Chronic Inflammatory Conditions
Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., which focuses on oncology, immunology, and critical care therapies, has announced the FDA approval of IMULDOSA (uste ...