European Commission: ODD for ASTX727 to Treat AML
The European Commission (EC) has granted orphan-drug designation (ODD) for Astex Pharma’s oral fixed dose ASTX727 to treat Acute Myeloid Leukemia (AML). AML, a blood cancer characterized by the overproduction of immature white blood cells within the bone marrow, is...
FDA RMAT Designation: Posoleucel to Treat Adenovirus (AdV)
The U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for AlloVir’s posoleucel (Viralym-M, ALVR105) to treat adenovirus (AdV) infection following allogeneic hematopoietic stem cell transplant (allo-HCT). AdV...
IND Approval: CStone Pharma’s CS5001 ADC to Target ROR1
Cstone Pharmaceuticals has announced the U.S. Food and Drug Administration’s (FDA) STUDY MAY PROCEED (SMP) letter and investigational new drug (IND) application approval for CS5001, a potential antibody-drug conjugate (ADC) to target receptor tyrosine kinase-like...
ImmixBio: FDA Approval for IMX-110 to Treat Pediatric Cancer
The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for ImmixBio’s IMX-110 for the treatment of a form of pediatric cancer in children. The cancer, rhabdomyosarcoma (RMS), is a malignant neoplasm and a very common sarcoma...
FDA Approval: Recorlev for Treatment of Cushing’s Syndrome
The U.S. Food and Drug Administration (FDA) has granted approval of Xeris Biopharma’s drug Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome. Endogenous Cushing’s syndrome is a rare, but serious and...
FDA Tentative Approval: Vasopressin Injectable Therapy
The U.S. Food and Drug Administration (FDA) has granted a tentative approval for Amphastar’s Abbreviated New Drug Application (ANDA) for an injectable vasopressin therapy to increase blood pressure in adults with vasodilatory shock. As part of the clinical syndrome of...
Lecanemab: FDA Fast Track Designation for AD Treatment
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Eisai’s lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer's disease (AD). Alzheimer's disease is a serious and progressive...
FDA Approval: Adbry Treatment for Atopic Dermatitis
Today, LEO Pharma announced the U.S. Food and Drug Administration’s (FDA) approval for the first and only treatment to target IL-13 cytokine in adults diagnosed with moderate to severe atopic dermatitis. Atopic dermatitis (eczema) is a chronic, inflammatory, skin...
Celularity: FDA Fast Track for CYNK-001 for Treatment of AML
The U.S. Food and Drug Administration (FDA) has approved Fast Track Designation for Celularity’s stem cell-derived natural killer (NK) cell therapy, CYNK-001, in the development for the treatment of acute myeloid leukemia (AML). AML is a type of blood cancer in which...
FDA Clearance: Royal Philip’s IVC Filter Removal Laser
The U.S. Food and Drug Administration (FDA) has granted De Novo Clearance for Royal Philip’s IVC filter removal laser sheath, CavaClear. IVC filters are used to treat patients with deep vein thrombosis (DVT), a condition in which blood clots form in the veins of the...
FDA Approval: First Injectable PrEP for HIV
The U.S. Food and Drug Administration (FDA) has given approval to start producing ViiV Healthcare’s cabotegavir, the first and only long-acting injectable pre-exposure prophylactic (PrEP) to reduce the risk of sexually acquired HIV-1. HIV-1 affects nearly 38 million...
FDA Approval: CAPLYTA to Treat Bipolar I and II Depression
Biopharmaceutical company, Intra-Cellular Therapies, has announced U.S. Food and Drug Administration (FDA) approval of CAPLYTA to treat bipolar I and bipolar II disorders. Bipolar is a mental disorder characterized by unusual mood swings, energy levels, and...
FDA Approval for Rakuten Medical’s IND for Cancer Cells
The U.S. Food and Drug Administration (FDA) has accepted Rakuten Medical’s, Inc. application for to begin clinical studies of the company’s investigational new drug (IND) for patients with advanced squamous cell carcinoma or patients with neck and head squamous cell...
NKX101: FDA Orphan Drug Designation for Nkarta’s AML Drug
In a potential development for clinical trial translations to come, the U.S. Food and Drug Administration (FDA) authorized orphan drug designation (ODD) to Nkarta’s engineered natural killer (NK) cell therapy NKX101 for the treatment of acute myeloid leukemia (AML)....
Nuvation Bio: FDA Fast Track Designation for NUV-422 Drug
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to NUV-422, a cyclin-dependent kinase (CDK) inhibitor developed by Nuvation Bio. NUV-422 was developed for the treatment of patients with high-grade gliomas, aggressive tumors that can be...
Chinook Therapeutics: Orphan Drug Designation for IgAN
Chinook Therapeutics announced that their drug, atrasentan, has been granted orphan drug designation by the European Commission for the treatment of primary IgA nephropathy (IgAN). The chronic kidney disease (CKD), IgAN, is the most common primary glomerular disease...
Natrunix: FDA Approves XBiotech’s IND Therapy
The US Food and Drug Administration’s (FDA) Division of Rheumatology has authorized the clinical development of XBiotech's Investigational New Drug (IND) Natrunix, a candidate antibody therapy to treat rheumatological diseases. Rheumatological disease, a condition...
FDA Approves Thermo Fisher’s CDx Cancer Tissue Test
The U.S. Food and Drug Administration (FDA) has granted premarket approval for Thermo Fisher's Oncomine Dx Target Test as a companion diagnostic (CDx) developed to help identify non-small cell lung cancer (NSCLC) patients. Lung cancer is the leading cause of cancer...
Aficamten Granted Breakthrough Designation for HCM treatment
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to aficamten, a cardiac myosin inhibitor, for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Hypertrophic cardiomyopathy (HCM) is a condition...
FDA Approves Saol Therapeutics’ LYVISPAH for MS Spasticity
The U.S. Food and Drug Administration (FDA) has approved Saol Therapeutics’ LYVISPAH (baclofen) oral granules for the treatment of spasticity, flexor spasms, concomitant pain, and muscular rigidity resulting from multiple sclerosis (MS). LYVISPAH, as opposed to...