U.S. FDA has granted NuCana Fast Track Designation for Acelarin® for the Treatment of Biliary Tract Cancer.
Acelarin (NUC-1031), which is currently being evaluated in a Phase III study (NuTide:121) for the first-line treatment of patients with advanced biliary tract cancer, has been granted Fast Track desig ...
FDA Approval for Zanubrutinib in Waldenstrom macroglobulinemia (WM)
According to BeiGene, the drug's manufacturer, the U.S. FDA has approved zanubrutinib (Brukinsa) capsules to treat adult patients with Waldenstrom macroglobulinemia (WM), a rare non-Hodgkin lymphoma. ...
Moderna Announces First Patient Dose in mRNA-3705 Phase 1/2 Study for Methylmalonic Acidemia (MMA).
Moderna, Inc., a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced today that the first patient had been enrolled in the Phase 1/2 study evaluat ...
Alkermes Receives U.S. FDA Fast Track Designation for Nemvaleukin Alfa for the Treatment of Mucosal Melanoma
Alkermes plc today announced that the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, nemvaleukin alfa (nemvaleukin), has been granted Fast Track designation by ...
U.S. FDA Grants Orphan Drug Designation to Tesomet In Hypothalamic obesity (HO)
Saniona, a clinical-stage biopharmaceutical company focused on rare diseases, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) to treat hypothalamic obesity (HO) ...
Rezolute, Inc. Receives FDA Orphan Drug Designation for Ersodetug for Hypoglycemia Due to Tumor Hyperinsulinism
Rezolute, Inc., a leading late-stage biopharmaceutical company focused on developing transformative therapies for rare diseases, announced that the U.S. Food and Drug Administration (FDA) has granted ...
Aquestive Therapeutics Receives Positive FDA Feedback for Anaphylm™ (Epinephrine) Sublingual Film
Aquestive Therapeutics Receives Positive FDA Feedback for Anaphylm™ (Epinephrine) Sublingual Film Aquestive Therapeutics, Inc., a trailblazing pharmaceutical company dedicated to improving patients ...
FDA Accepts Cytokinetics’ NDA for Aficamten to Treat Obstructive Hypertrophic Cardiomyopathy
FDA Accepts Cytokinetics' NDA for Aficamten to Treat Obstructive Hypertrophic Cardiomyopathy Cytokinetics, Incorporated today announced that the U.S. Food & Drug Administration (FDA) has accepted ...
FDA Grants Orphan Drug Designation to AAVantgarde Bio’s AAVB-081 for Usher Syndrome Type 1B Treatment
FDA Grants Orphan Drug Designation to AAVantgarde Bio's AAVB-081 for Usher Syndrome Type 1B Treatment AAVantgarde Bio (AAVantgarde), a clinical-stage, Italian-based international biotechnology company ...
Amneal Pharmaceuticals Advances Key Strategic Initiatives with FDA Submissions and Approvals
Amneal Pharmaceuticals Advances Key Strategic Initiatives with FDA Submissions and Approvals Amneal Pharma, a global leader in pharmaceuticals, today announced the progression of two significant strat ...