The FDA approval process is complex and involves multiple steps. Understanding how a prescription drug becomes available over the counter (OTC) is essential for healthcare professionals, members of the pharmaceutical industry, and...
The FDA approval process is multi-faceted and involves several aspects. One of these aspects is accelerated approval, which is meant to approve drugs to treat severe or fatal diseases. According to a...
Earlier this week, the FDA and NIH announced their launch of a public–private partnership for research on rare neurodegenerative diseases. The partnership, called the Critical Path for Rare...
Results from the Phase III CodeBreaK 200 clinical trial found that Amgen’s targeted therapy Lumakras successfully extended progression-free survival (PFS) by about two months and was 15% more...
A retrospective cohort study was conducted using data from January 1, 2004, to December 31, 2018. The researchers reviewed information from the FDA and the European Medicines Agency (EMA) to determine...
A study published on September 1st in the New England Journal of Medicine tracking health data from 109,254 Israeli adults found a 73% reduction in hospitalization and a 79% reduction in COVID-19...
The FDA’s Report on The State of Pharmaceutical Quality is published annually to analyze quality measures related to drug manufacturers and products. The report looked at manufacturing site...
As the COVID pandemic progresses and new variants appear, clinicians and public health professionals have been concerned about the level of vaccine protection for new variants and subvariants. To...
In January 2022, Omnipod 5 was first approved for anyone over six. Omnipod 5 is the first tubeless automated insulin delivery (AID) made available in the United States for a broad age range. Recently,...
Ebola virus disease (EVD) is a potentially fatal disease caused by infection with ebolavirus. This WHO statement regards EVD caused by the Zaire ebolavirus. Following a review of many randomized...
On August 19, 2022, the FDA approved AUVELITY — an oral medication manufactured by Axsome Therapeutics — for the treatment of major depressive disorder (MDD) in adults. This medication...
Alongside Kyleena and Liletta, Mirena is one of three hormonal intrauterine devices (IUD) available in the United States. Previously, the duration of use for Mirena was seven years, at which point the...
As the COVID pandemic progresses and infection rates fluctuate, public health officials and organizations seek to provide more options to protect against illness. On August 19, Novavax announced that...
On August 17, 2022, the FDA approved bluebird bio's Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy to treat patients with beta thalassemia who need regular red blood...
Recently, the FDA approved the sale of some over-the-counter (OTC) hearing aids, widening access to those who need them. According to the National Institute on Deafness and Other Communication...
Monkeypox was declared a public health emergency by the WHO on Saturday, July 23, 2022. Since the rise of monkeypox rates, public health organizations have urged at-risk populations to seek...
In the United States, drug prices have soared in recent years. The pharmaceutical industry and medicine, in general, have been criticized for these rising drug costs. Beyond the associated financial burden, inflated medication costs also...
On April 28, 2022, the FDA placed a total ban on all flavored nicotine products in an attempt to reduce the number of nicotine-related diseases and illnesses. Following previous FDA rulings to ban...
Lyons Magnus LLC, a part of the food service industry, recently recalled several products due to potential microbial contamination. In the company statement, Cronobacter sakazakii and Clostridium...
On Saturday, July 23, 2022, the director-general of the WHO declared monkeypox a public health crisis. Public health organizations have encouraged vaccination for at-risk populations to minimize the...
