FDA Roundup: March 22, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Approves Duvyzat (givinostat) for Duchenne Muscular Dystrophy
MILAN--(BUSINESS WIRE)-- Mar 22, 2024 -- Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertension
RARITAN, NJ, March 22, 2024– Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi®– a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2024 Category: Drugs & Pharmacology Source Type: news
U.S. Food and Drug Administration (FDA) Grants Full Approval for Elahere (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients
The full approval of Elahere is based on the confirmatory MIRASOL Phase 3 trial that supports the medicine as a potential new standard of care for folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer (PROC)
Data show that... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2024 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Broad New Labels for Nexletol and Nexlizet to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use
ANN ARBOR, Mich., March 22, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for Nexletol (bempedoic acid) Tablets and Nexlizet... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2024 Category: Drugs & Pharmacology Source Type: news
EMA Approves Ocular Formulation of Bevacizumab EMA Approves Ocular Formulation of Bevacizumab
Europe has approved the use of monoclonal antibody bevacizumab for the treatment of neovascular age-related macular degeneration.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - March 22, 2024 Category: Drugs & Pharmacology Tags: Ophthalmology Source Type: news
FDA Rationale for Piperacillin Tazobactam Breakpoints for Pseudomonas aeruginosa
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Ceftazidime – Injection products
; Exceptions to the recognized standard of CLSI M100 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
EU Backs First Oral Monotherapy for Adults With PNH EU Backs First Oral Monotherapy for Adults With PNH
The European Medicines Agency has recommended Fabhalta for treating paroxysmal nocturnal hemoglobinuria after reviewing clinical trial results.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - March 22, 2024 Category: Drugs & Pharmacology Tags: Hematology-Oncology Source Type: news
Drug Trials Snapshots: POMBILITI
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 22, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
AI May Help Docs Reply to Patients' Portal Messages AI May Help Docs Reply to Patients' Portal Messages
Easing the burden on providers of responding to each question in a patient portal is a target ripe for solutions.MDedge News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - March 22, 2024 Category: Drugs & Pharmacology Tags: Internal Medicine Source Type: news
Acne Products With Benzoyl Peroxide Under Scrutiny Acne Products With Benzoyl Peroxide Under Scrutiny
In a citizen ' s petition, Valisure asked the FDA to recall acne products with benzoyl peroxide, stirring debate.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - March 22, 2024 Category: Drugs & Pharmacology Tags: Dermatology Source Type: news
FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
The FDA approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 21, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 21, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Novo Nordisk's Once-weekly Basal Insulin Icodec Recommended for Marketing Approval in Europe Novo Nordisk's Once-weekly Basal Insulin Icodec Recommended for Marketing Approval in Europe
Danish drugmaker Novo Nordisk on Thursday said its once-weekly basal insulin icodec for treatment of diabetes in adults had received a recommendation for marketing...Reuters Health Information (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - March 21, 2024 Category: Drugs & Pharmacology Tags: Diabetes & Endocrinology Source Type: news
