Atriva receives FDA Orphan Drug Designation for Zapnometinib to treat Hantavirus Infections
Atriva Therapeutics GmbH, a biopharmaceutical company pioneering the development of host-targeting antiviral therapies, announced today that its lead candidate, zapnometinib (ATR-002), has received Or ...
FDA approves treatment for schizophrenia in pediatric patients
Otsuka and Lundbeck's supplemental new drug application (sNDA) for brexpiprazole to treat schizophrenia in pediatric patients aged 13 to 17 years has been approved by the US Food and Drug Administrati ...
SK life science Initiates Carisbamate Phase 3 Clinical Trial for Lennox-Gastaut Syndrome
SK Life Science, Inc. has submitted a Phase 3 clinical trial protocol to the US Food and Drug Administration (FDA) to assess the efficacy and safety of carisbamate for the treatment of seizures associ ...
Cullinan Oncology’s CLN-081 Receives Breakthrough Therapy Designation for NSCLC
Cullinan Oncology's CLN-081, an orally available, irreversible EGFR inhibitor, today received an FDA's Breakthrough Therapy Designation to treat locally advanced or metastatic non–small cell lung canc ...
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 ...