Before the FDA Modernization Act 2.0 was passed in December 2022, the US government required that all investigational drugs be tested on animals before they could advance to human trials. Although this act does not ban animal testing, it...
On January 24, 2024, the FDA issued a new draft guidance regarding lead levels in processed baby food meant for children under two as part of its Closer to Zero initiative. The Closer to Zero...
On January 27, 2023, the FDA issued a press release linking its new draft recommendation for updated blood donation guidelines. These updated guidelines take a more modern and individual approach to...
Like developing, launching, and marketing any product, drug development and launching is a complex, costly, and intricate process. However, unlike other markets, the pharmaceutical industry has an added layer of complexity associated with...
On December 29, 2022, President Biden signed the FDA Modernization Act 2.0 into law, allowing clinical trial leaders to use animal trial alternatives before human clinical trials. Senators Rand Paul,...
Based on the results of a double-blind, placebo-controlled, the FDA granted the accelerated approval of Leqembi for Alzheimer’s disease, making it the second approved medication targeting the...
Human immunodeficiency virus (HIV), a viral infection that attacks and weakens the immune system, impacts 38.4 million people worldwide. According to the WHO, in 2021, 650,000 people globally died of an HIV-related illness. Despite high...
In a step towards widening access, the FDA made a regulatory change, allowing the abortion pill, mifepristone, to be distributed by retail pharmacies with a valid prescription. Mifepristone is one...
Like any industry, recalls in the pharmaceutical industry are complex and expensive. However, as an added concern, pharmaceutical recalls have the potential to alter short and long-term health outcomes. Understanding the recall process for...
Throughout the COVID-19 pandemic, the FDA has played a critical role in addressing public health concerns by encouraging practices to minimize infectious disease spread and expediting approval for...
Last week, the FDA approved Gilead Science’s Sunlenca (lenacapavir), the first and only capsid inhibitor-based HIV treatment. The treatment is intended for adult patients whose HIV cannot be...
Major depressive disorder (MDD) — commonly referred to as depression — affects approximately 20% of adults in the United States. MDD symptoms may include depressed mood, appetite changes,...
Across every pharmacy, grocery store, and convenience store in the United States, dietary supplements — in some shape or form — line the shelves. Many patients have the misconception that because these products are sold and...
According to a recent press release, Janssen recently submitted a Biologics License Application (BLA) to the FDA for talquetamab to treat relapsed or refractory multiple myeloma. The CDC states that...
The United States Food and Drug Administration (FDA) approval process is complex and involves multiple people's input, opinions, and expertise, including the FDA advisory committees. Every time a new drug is approved, a recall is...
Biosimilars have gained significant traction in healthcare for being more affordable alternatives to biological products. Despite the importance and benefits of biosimilars, many providers are hesitant...
Last week, the FDA’s Center for Biologics Evaluation and Research announced the approval of Hemgenix, an adeno-associated virus vector-based gene therapy for adults with hemophilia B (congenital...
In a Drug Safety Communication issued on November 22, 2022, the FDA announced that it is investigating Prolia and its associations with severe hypocalcemia — low blood calcium levels — in...
Clarity Pharmaceuticals recently announced its Investigational New Drug (IND) approval from the FDA to test theranostic SAR-Bombesin for prostate cancer. Prostate cancer is the fifth leading cause of...
The American Cancer Society states that ovarian cancer is the fifth leading cause of cancer-related death in women in the United States. The organization also says that, in 2022, nearly 13,000 people...
