FDA Grants Orphan Drug Designation to ATYR1923 for Sarcoidosis Treatment
aTyr Pharma, Inc., a clinical-stage biotherapeutics company focused on the discovery and development of novel medicines based on novel biological pathways, announced today that the U.S. Food and Drug ...
Pharming Receives EMA Approval for PIP for Leniolisib
Commercial-stage biopharmaceutical company, Pharming Group, has been granted a positive opinion by the European Medicines Agency (EMA) for its Paediatric Investigation Plan (PIP) for leniolisib. Lenio ...
European Commission has designated oral decitabine and cedazuridine as orphan drugs for the treatment of Acute myeloid leukemia (AML)
Astex Pharmaceuticals, Inc. today announces that the European Commission (EC) has granted orphan-drug designation to the oral fixed-dose combination of decitabine and cedazuridine for the treatment of ...
SpliSense Announces EMA and FDA Grant Orphan Drug Designation to SPL84-23-1 for the Cystic Fibrosis Treatment
SpliSense, a biopharmaceutical company developing transformative mRNA-altering therapies for cystic fibrosis (CF) and other pulmonary diseases, today announced that the U.S. Food and Drug Administrati ...
Everest Medicines Announces Taiwan FDA Has Accepted New Drug Application for Sacituzumab Govitecan in Second-Line Metastatic Triple-Negative Breast Cancer
Everest Medicines Limited, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Asia, announced today that the Taiwan FDA had accepted the su ...
Genprex Receives U.S. FDA Fast Track Designation for REQORSA™ in Combination With Keytruda® for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
Genprex, Inc., today announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track Designation (FTD) for the Company’s lead drug candidate, REQORSA™ Immunogene Therapy, in combinat ...
Bionomics has begun the Phase 2 PREVAIL study of BNC210 for the Acute Treatment of Social Anxiety Disorder (SAD).
Bionomics Limited is pleased to announce that it has initiated its Phase 2 clinical trial (the PREVAIL Study) to evaluate BNC210 for the acute treatment of Social Anxiety Disorder (SAD), with topline ...
Spero Therapeutics Announces FDA Acceptance and Priority Review of Tebipenem HBr New Drug Application for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis
Spero Therapeutics, Inc. today announced that the U.S. FDA has granted Priority Review designation and confirmed acceptance for substantive review of the New Drug Application (NDA) seeking approval fo ...
FDA grants rare pediatric disease designation to IMX-110 for Rhabdomyosarcoma (RMS) treatment
Immix Biopharma, Inc., a biopharmaceutical company that pioneered Tissue-Specific Therapeutics (TSTx)TM for oncology and immuno-dysregulated diseases, announced today that the U.S. Food and Drug Admin ...
U.S. FDA Grants Orphan Drug Exclusivity for Xywav® Oral Solution for Idiopathic hypersomnia (IH) in Adults
The United States Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity (ODE) to Jazz Pharmaceuticals plc's Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution f ...