FDA Approves Merck ’s Welireg (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI
RAHWAY, N.J.--(BUSINESS WIRE) December 14, 2023 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Welireg, an oral hypoxia-inducible factor-2... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 14, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves iDose TR (travoprost intracameral implant) for the Treatment of Glaucoma
ALISO VIEJO, Calif.--(BUSINESS WIRE) December 14, 2023 -- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 14, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Updates LDL-C Lowering Indication for Esperion ’s Nexletol (bempedoic acid) Tablet and Nexlizet (bempedoic acid and ezetimibe) Tablet
Updated Label Adds Primary Hyperlipidemia, Removes Maximally Tolerated Statin Requirement, Removes Limitation of Use
Cardiovascular (CV) Risk Reduction Labels Remain on Track: in U.S. with PDUFA Date of March 31; in Europe with Anticipated... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 13, 2023 Category: Drugs & Pharmacology Source Type: news
Theratechnologies Announces FDA Approval of Trogarzo 90-Second Intravenous (IV) Push Loading Dose
Updated label means new Trogarzo® patients no longer require initiation of treatment by 30-minute infusion
Complete IV push method enables easier and more convenient administration of Trogarzo® for heavily treatment-experienced adults... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 13, 2023 Category: Drugs & Pharmacology Source Type: news
ADMA Biologics Announces FDA Approval for Bivigam in the Pediatric Patient Setting for Those 2 Years of Age and Older
Signifies the Successful Fulfillment of Bivigam’s Post Marketing Commitments as Part of the Original BLA Approval
Expanded Label in the U.S. Now Includes Pediatric PI Patients 2 Years of Age and Older
RAMSEY, N.J. and BOCA RATON, Fla.,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 12, 2023 Category: Drugs & Pharmacology Source Type: news
bluebird bio Announces FDA Approval of LYFGENIA ™ (lovotibeglogene autotemcel) for Patients Ages 12 and Older with Sickle Cell Disease and a History of Vaso-Occlusive Events
SOMERVILLE, Mass.--(BUSINESS WIRE)--Dec. 8, 2023-- bluebird bio, Inc. (Nasdaq: BLUE) (“bluebird bio” or“bluebird”) today announced the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 10, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Lyfgenia (lovotibeglogene autotemcel) for Patients Ages 12 and Older with Sickle Cell Disease and a History of Vaso-Occlusive Events
SOMERVILLE, Mass.--(BUSINESS WIRE)--Dec. 8, 2023-- bluebird bio, Inc. (Nasdaq: BLUE) (“bluebird bio” or“bluebird”) today announced the U.S. Food and Drug Administration (FDA) has approved Lyfgenia (pronounced as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 8, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Casgevy (exagamglogene autotemcel) CRISPR/Cas9 Genome-Edited Cell Therapy for the Treatment of Sickle Cell Disease
BOSTON & ZUG, Switzerland--(BUSINESS WIRE)--Dec. 8, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 8, 2023 Category: Drugs & Pharmacology Source Type: news
First-ever approval of a CRISPR-based gene-editing therapy in the U.S., Casgevy (exagamglogene autotemcel) for the Treatment of Sickle Cell Disease
BOSTON & ZUG, Switzerland--(BUSINESS WIRE)--Dec. 8, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 8, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Casgevy (exagamglogene autotemcel) for the Treatment of Sickle Cell Disease
– First-ever approval of a CRISPR-based gene-editing therapy in the U.S. – Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 8, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Expanded Use of Cresemba (isavuconazonium sulfate) in Children with Invasive Aspergillosis and Invasive Mucormycosis
Cresemba is the only azole antifungal therapy approved for pediatric patients as young as one affected by these serious, potentially life-threatening infections
Approval based on results of two pediatric studies in children aged 1 to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 8, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Grants Expanded Approval to Wilate as the First VWF Concentrate for Prophylaxis in All Types of VWD
Paramus, NJ 07/12/2023 Octapharma USA announced the expansion of the U.S. Food and Drug Administration (FDA) approval for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 7, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Avzivi (bevacizumab-tnjn), a Biosimilar to Avastin
GUANGZHOU, China, Dec. 7, 2023 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today announced that the United States Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 7, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Fabhalta (iptacopan) for the Treatment of Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Basel, December 6, 2023— Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)1.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 6, 2023 Category: Drugs & Pharmacology Source Type: news
Jaypirca (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor
The first and only non-covalent (reversible) BTK inhibitor, Jaypirca has been shown to extend the benefit of BTK inhibition
In the BRUIN Phase 1/2 trial, adult patients with CLL/SLL who have received at least two lines of therapy, including a BTK... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2023 Category: Drugs & Pharmacology Source Type: news
