Dupixent (dupilumab) FDA Approved as First and Only Treatment Indicated for Children Aged 1 Year and Older with Eosinophilic Esophagitis (EoE)
TARRYTOWN, N.Y. and PARIS, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 25, 2024 Category: Drugs & Pharmacology Source Type: news
Heron Therapeutics Announces FDA Approval of Zynrelef Indication Expansion to Include Additional Orthopedic and Soft Tissue Procedures
SAN DIEGO, Jan. 23, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (the " FDA " ) has approved its supplemental New Drug Application... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 23, 2024 Category: Drugs & Pharmacology Source Type: news
U.S. Food and Drug Administration Grants Full Approval for Balversa to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations
Balversa® is the First and Only Targeted Therapy for Patients with Locally Advanced or Metastatic Urothelial Carcinoma and Susceptible Fibroblast Growth Factor Receptor Alterations
Phase 3 THOR Study Showed a 36 Percent Reduction in the Risk... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 19, 2024 Category: Drugs & Pharmacology Source Type: news
Vertex Announces US FDA Approval of Casgevy (exagamglogene autotemcel) for the Treatment of Transfusion-Dependent Beta Thalassemia
BOSTON--(BUSINESS WIRE)--Jan. 16, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has approved Casgevy™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 16, 2024 Category: Drugs & Pharmacology Source Type: news
Dupixent (dupilumab) U.S. Label Updated with Data Further Supporting Use in Atopic Dermatitis with Moderate-to-Severe Hand and Foot Involvement
TARRYTOWN, N.Y. and PARIS, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has updated the label for Dupixent® (dupilumab) in atopic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 16, 2024 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Takeda ’s Hyqvia as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], the Only up to Once Monthly (every 2, 3 or 4 weeks) Subcutaneous Immunoglobulin (SCIG) Infusion to Treat CIDP, Can Be Administered by a Healthcare Professional or... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 16, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Merck ’s Keytruda (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer
Keytruda is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients
Approval marks third FDA-approved indication for Keytruda in cervical cancer and 39th indication for Keytruda in the US
RAHWAY,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 12, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Zelsuvmi (berdazimer topical gel) for the Treatment of Molluscum Contagiosum
SAN DIEGO--(BUSINESS WIRE) January 5, 2024 -- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that the U.S. Food and Drug Administration (FDA) has approved Zelsuvmi™ (berdazimer topical gel, 10.3%) for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 5, 2024 Category: Drugs & Pharmacology Source Type: news
Coherus Announces FDA Approval of Udenyca Onbody ™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv
Innovative design enables five-minute pegfilgrastim delivery time
Unique, automatic, retractable needle mechanism engineered to maximize safety and comfort for cancer patients receiving pegfilgrastim
REDWOOD CITY, Calif., Dec. 26, 2023 (GLOBE... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 26, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Label Update for Brukinsa (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL)
U.S. label update includes superior progression-free survival results from the Phase 3 ALPINE head-to-head trial of Brukinsa versus Imbruvica® (ibrutinib) in Relapsed or Refractory CLL
ALPINE is the only Phase 3 Bruton’s tyrosine kinase... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Wainua (eplontersen) for the Treatment of Adults with Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis
U.S. FDA approval based on Phase 3 NEURO-TTRansform results showing Wainua demonstrated consistent and sustained benefit halting neuropathy disease progression and improving neuropathy impairment and quality of life
Additional regulatory reviews... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Label Update for Kite ’s Yescarta CAR T-Cell Therapy to Include Overall Survival Data
Yescarta is the First and Only Treatment in Nearly 30 Years to Demonstrate Superior Overall Survival for Patients with Relapsed/Refractory Large B-cell Lymphoma Versus Standard of Care as Second-Line Treatment With Curative Intent*
SANTA... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2023 Category: Drugs & Pharmacology Source Type: news
Calliditas Therapeutics Announces Full FDA Approval of Tarpeyo, the Only FDA-Approved Treatment for IgA Nephropathy to Significantly Reduce the Loss of Kidney Function
December 20, 2023 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), today announced that the U.S. Food and Drug Administration (FDA) has approved Tarpeyo (budesonide) delayed release capsules to reduce... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 20, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Filsuvez (birch triterpenes) Topical Gel for the Treatment of Epidermolysis Bullosa
BOSTON, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 19, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Alyglo (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)
YOGIN, South Korea, Dec. 17, 2023 /PRNewswire/ -- GC Biopharma Corp (006280.KS) today announces that the US Food and Drug Administration (FDA) has approved Alyglo (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 17, 2023 Category: Drugs & Pharmacology Source Type: news
