Diadem’s AlzoSure Predict: Breakthrough Device Designation
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Diadem’s AlzoSure Predict, a blood-based biomarker prognostic assay designed to identify early signs of Alzheimer’s disease and determine the potential rate of progression in...
FDA Approval: AbbVie’s RINVOQ to Treat Atopic Dermatitis
AbbVie has announced the U.S. Food and Drug Administration (FDA) approval for RINVOQ (upadacitinib) to treat refractory, moderate to severe atopic dermatitis in children 12 years and older and adults. Atopic dermatitis, more commonly known as eczema, is a chronic skin...
FDA IND Clearance: Topical Agent to Treat Dry Eye Disease
The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for Aramis Biosciences’ immunomodulatory agent, A197, for the treatment of dry eye disease. Dry eye disease is a common, chronic, immune-mediated disease that is...
CBMG: FDA Designations for Cell Therapy to Treat DLBCL
The U.S. Food and Drug Administration (FDA) has granted both a Fast Track Designation and a Regenerative Medicine Advanced Therapy Designation (RMAT) to Cellular Biomedicine’s (CBMG) autologous b-specific therapy, C-CAR039, for the treatment of patients with diffuse...
FDA IND Approval: SNIPR001 to Target E. coli Infections
SNIPR BIOME has announced the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug (IND) application for SNIPR001 to target E. coli infections in cancer patients. E. coli bacteria live in the intestines of healthy people and while most...
Advanced NSCLC: EC Approval of Lumykras Treatment
The European Commission (EC) has granted a conditional marketing authorization for Amgen’s LUMYKRAS (sotorasib) to treat advanced non-small cell lung cancer (NSCLC) with the KRAS G12C mutation in adults. NSCLC is the leading lung cancer diagnosis globally and includes...
FDA sNDA: REXULTI to Treat Pediatric Schizophrenia
The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Otsuka and H. Lundbeck’s drug REXULTI for the treatment of schizophrenia in pediatric patients aged 13 to 17. Schizophrenia is a life-long serious disease that is...
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...