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

FDA Approves Tryvio (aprocitentan) for the Combination Treatment of Resistant Hypertension
RADNOR, Pa., March 20, 2024 /PRNewswire/ -- Idorsia Pharmaceuticals U.S. Inc. announced today that the US Food and Drug Administration (FDA) has approved Tryvio™ (aprocitentan) for the treatment of hypertension in combination with other... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 20, 2024 Category: Drugs & Pharmacology Source Type: news

Pressure grows to ditch controversial forced swim test in rodent studies of depression
For the past few decades, scientists studying candidate antidepressant drugs have had a convenient animal test: how long a rodent dropped in water keeps swimming. Invented in 1977 , the forced swim test (FST) hinged on the idea that a depressed animal would give up quickly. It seemed to work: Antidepressants and electroconvulsive therapy often made the animal try harder. The test remains popular, appearing in about 600 papers per year . But researchers have recently begun to question the assumption that the test really gauges depression and is a good predictor of human responses to drugs. Oppositi...
Source: ScienceNOW - March 20, 2024 Category: Science Source Type: news

Pyramid Wholesale Issues Recall of Various Brands of Products Sold as Dietary Supplements for Sexual Enhancement Because They Contain Undeclared Prescription Drugs Including Sildenafil (Viagra) and/or Tadalafil (Cialis)
Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 20, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act RIA (Proposed Rule)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 20, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 20, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Secondary Cancers Post CAR T Therapy: A Concern? Secondary Cancers Post CAR T Therapy: A Concern?
An analysis of the FAERS database found the incidence of secondary cancers following CAR T therapy represented 4.3% of all adverse events; however, only 0.1% were secondary T-cell malignancies.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - March 20, 2024 Category: Drugs & Pharmacology Tags: Hematology-Oncology Source Type: news