FDA Roundup: April 26, 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 - April 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Approves New Antibiotic for Uncomplicated UTIs FDA Approves New Antibiotic for Uncomplicated UTIs
The US Food and Drug Administration has approved pivmecillinam (Pivya) tablets to treat uncomplicated urinary tract infections in women.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - April 26, 2024 Category: Drugs & Pharmacology Tags: Family Medicine/Primary Care News Alert Source Type: news
Important Addresses for Regulatory Submissions
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
How physicians interpret information about prescription drugs in scientific publications vs. promotional pieces
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
2024 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments - 06/06/2024
The Food and Drug Administration (FDA or the Agency) is announcing its annual public meeting and opportunity for public comment on “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Drug for Overactive Bladder Recommended in Europe Drug for Overactive Bladder Recommended in Europe
Obgemsa is suitable for treating symptoms of an overactive bladder in adults, the European Medicines Agency has determined.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - April 26, 2024 Category: Drugs & Pharmacology Tags: Urology News Alert Source Type: news
New Contraindications to Coadministration of Atazanavir New Contraindications to Coadministration of Atazanavir
New restrictions have been imposed by the European Medicines Agency on the coadministration of the anti-HIV drug atazanavir with a variety of other agents.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - April 26, 2024 Category: Drugs & Pharmacology Tags: HIV/AIDS News Alert Source Type: news
Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
A Milestone in Facilitating the Development of Safe and Effective Biosimilars
The 50th biosimilar approval milestone also reflects our strategic approach to biosimilars, as outlined in the FDA ’s Biosimilars Action Plan. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 26, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Peptides, proteins, and the risks of cardiac arrythmias: A CDER study suggests that the human Thorough QT study is not needed for products comprised of naturally occurring amino acids
Peptides, proteins, and the risks of cardiac arrythmias: a CDER study suggests that the human Thorough QT study is not needed for products comprised of naturally occurring amino acids (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 25, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections
April 24, 2024 -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 24, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves New Treatment for Uncomplicated Urinary Tract Infections
Today, the FDA approved a new treatment for female adults with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 24, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Tuan delivers annual Last Lecture
The Department of Cellular and Molecular Pharmacology faculty member was selected by students to answer: If you had but one lecture to give, what would you say? (Source: UCSF School of Pharmacy News)
Source: UCSF School of Pharmacy News - April 24, 2024 Category: Universities & Medical Training Source Type: news
A novel network pharmacology strategy based on the universal effectiveness-common mechanism of medical herbs uncovers therapeutic targets in traumatic brain injury - Yu Z, Ding R, Yan Q, Cheng M, Li T, Zheng F, Zhu L, Wang Y, Tang T, Hu E.
PURPOSE: Many herbs can promote neurological recovery following traumatic brain injury (TBI). There must lie a shared mechanism behind the common effectiveness. We aimed to explore the key therapeutic targets for TBI based on the common effectiveness of th... (Source: SafetyLit)
Source: SafetyLit - April 24, 2024 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
FDA Grants Accelerated Approval for Ojemda (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma
BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the“Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 23, 2024 Category: Drugs & Pharmacology Source Type: news
