ChemomAb’s CM-101 Receives FDA Clearance for Phase 2 trial in Adults with Systemic Sclerosis (SSc)
ChemomAb Ltd. has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) Application to assess CM-101 in a Phase 2 trial for systemic sclerosis (SSc ...
Biohaven’s Taldefgrobep Alfa Receives Fast Track Designation from FDA for Treating Spinal Muscular Atrophy
Biohaven Ltd. has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its novel anti-myostatin adnectin, taldefgrobep alfa, for treating spinal muscular atrophy (SMA). ...
FDA Accepts Blueprint Medicine’s AYVAKIT® Supplemental NDAs for Treatment of Indolent Systemic Mastocytosis
Blueprint Medicines announces FDA acceptance of AYVAKIT® supplemental NDA for indolent systemic mastocytosis treatment. FDA grants priority review with May 22, 2023 action date under PDUFA. Results fr ...
CARsgen Announces CT041 Granted RMAT Designation by the FDA
CARsgen Therapeutics Holdings Limited, a company primarily focused on developing novel CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced today that CT041 h ...
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 ...
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 ...
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 ...
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 ...