Tonix Pharmaceuticals Submits NDA for TNX-102 SL to Treat Fibromyalgia
Tonix Pharmaceuticals Holding Corp. has announced the submission of a NDA to the U.S. Food and Drug Administration (FDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid, c ...
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 ...