Government

FDA
May has been a fairly slow month for approvals by the U.S. Food and Drug Administration (FDA). There are currently only two scheduled for the rest of the month, with a third that has been withdrawn. Let’s take a look.
Companies that generate revenue less than $100 million would not have to undergo regular outside audits.
Johnson & Johnson has lost several major lawsuits over allegations that asbestos in its talcum powder contributes to ovarian cancer.
The company is pledging to support a goal to end HIV in the U.S. by 2030 announced by the president during the State of the Union this year.
Today has been marked by a wide range of life science and biopharma stories. Here’s a broader look at some of the top stories.
The inclusion of the list price is part of an effort from the administration to lower the cost of prescription drugs. The industry’s lobbying arm believes the inclusion will be confusing to patients.
Companies from across the globe provide updates to their pipelines and businesses, with news from BioNTech, Mologic, Akcea, RedHill, and more.
Over and over there are reports about the increasing rise of antibiotic resistant bugs. Even as the number of resistant bacteria increases, the number of companies developing new types of antibiotics is decreasing.
FDA
On March 27, the U.S. Food and Drug Administration (FDA) approved Novartis’ Mayzent (isiponimod) for adults with relapsing types of multiple sclerosis.
FDA
The Jacobus LEMS Drug was approved for pediatric patients. However, the approval was based on results from a study of adult patients, which means that doctors could opt to prescribe this medication for adult LEMS patients.
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