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 ...
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 ...
Hope Medicine Inc. Announces Positive Phase 2 Results for HMI-115 in Endometriosis Treatment
Hope Medicine Inc., a clinical-stage innovative biopharmaceutical company, announced positive results from an interim analysis of a global Phase 2 study, titled "A Randomized, Multicenter, Double-Blin ...
Dizal’s Sunvozertinib Receives Breakthrough Therapy Designation for First-Line NSCLC Treatment
Dizal, a biopharmaceutical company dedicated to the development of novel treatments for cancer and immunological diseases, has announced that the Center for Drug Evaluation (CDE) of China's National M ...
FDA Grants Breakthrough Therapy Designation to Mirum’s Volixibat for Cholestatic Pruritus in PBC
Mirum Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has awarded Breakthrough therapy designation to their drug, volixibat, as a potential treatment for cholestat ...
INOVIO’s INO-3107 Granted FDA Breakthrough Therapy Designation for RRP Treatment
INOVIO Pharmaceuticals, a leading biotechnology company, has received the FDA's Breakthrough Therapy designation for INO-3107. This DNA medicine shows promise in treating Recurrent Respiratory Papillo ...
SAB Biotherapeutics’ SAB-176 Granted Breakthrough Therapy Designation by FDA for High-Risk Patients with Type A and B Influenza
SAB Biotherapeutics receives the FDA's Breakthrough Therapy Designation for SAB-176, an investigational therapeutic for post-exposure prophylaxis of Type A and Type B influenza illness in high-risk pa ...
Moderna’s mRNA-1345 Receives Breakthrough Designation from FDA for Respiratory Syncytial Virus (RSV) Prevention
Moderna, a biotechnology company pioneering mRNA therapeutics and vaccines, announced that mRNA-1345, its investigational mRNA vaccine for respiratory syncytial virus (RSV), has received Breakthrough ...
Abbisko Therapeutics’ Pimicotinib (ABSK021) Receives Breakthrough Therapy Designation from FDA for Treatment of Tenosynovial Giant Cell Tumor
Abbisko Therapeutics today announced that its CSF-1R inhibitor Pimicotinib（ABSK021）has been granted the breakthrough therapy designation from FDA for the treatment of tenosynovial giant cell tumor (TG ...
IVERIC bio’s Avacincaptad Pegol Receives Breakthrough Therapy Status from FDA for Geographic Atrophy Treatment
IVERIC bio, Inc. announces U.S. FDA Breakthrough Therapy designation for avacincaptad pegol (Zimura®), a novel investigational complement C5 inhibitor for treating Geographic atrophy (GA) secondary to ...