Each week we highlight five things affecting the life sciences industry. Here's the latest. FDA releases final rule on laboratory developed tests On April 29, the U.S. Food and Drug Administration issued a final rule regarding regulation of laboratory developed tests, following a proposed rule in ... READ MORE >
FDA
Key takeaways for life sciences on laboratory developed tests final rule
The U.S. Food and Drug Administration released a final rule yesterday regarding the regulation of laboratory developed tests, also known as LDTs. This final rule follows a proposed rule that was released last fall. While the final rule closely follows the proposed rule released late last year, there are ... READ MORE >
5 things to know in life sciences: Week of Feb. 26, 2024
Each week we highlight five things affecting the life sciences industry. Here's the latest. 3D bioprinting: New era in regenerative medicine Recent advancements in 3D bioprinting, including the development of functional human brain tissue and replacement tissue for treating injured cartilage, signal ... READ MORE >
5 things to know in life sciences: Week of Feb. 19, 2024
Each week we highlight five things affecting the life sciences industry. Here's the latest. FDA warns against fraudulent data in medical device premarket submissions The U.S. Food and Drug Administration is alerting medical device manufacturers about the rise in fraudulent and unreliable laboratory ... READ MORE >
5 things to know in life sciences: Week of Dec. 18, 2023
This week we highlight a potential U.S. Food and Drug Administration subpoena amid a probe into overseas inspections. We also look at a divestiture of an early cancer-detection company following a Federal Trade Commission challenge. Additionally, we explore the approval of the first DNA test to identify ... READ MORE >
5 things to know in life sciences: Week of Oct. 9, 2023
This week, we delve into Bristol Myers Squibb's significant acquisition of Mirati Therapeutics. Also, we look at the U.S. Food and Drug Administration’s formation of a digital health advisory committee and the groundbreaking approval of a genetic test for cancer risk assessment. Additionally, we spotlight ... READ MORE >
5 things to know in life sciences: Week of July 31, 2023
This week we spotlight a groundbreaking wearable ultrasound scanner, the invention of a tiny tentacled robot for potential early lung cancer detection, as well as the appointment of a new director at the National Institute of Allergy and Infectious Diseases. Additionally, we look at the approval of a ... READ MORE >
5 things to know in life sciences: Week of July 24, 2023
This week we spotlight the Food and Drug Administration’s improved decision times on 510(k) submissions. We also delve into a clinical trial that shows the effects of pitavastatin calcium on reducing cardiovascular events in people with HIV, as well as artificial intelligence systems for accurate blood ... READ MORE >
5 things to know in life sciences: Week of June 19, 2023
This week we spotlight the significant uptick in biotech layoffs in the first quarter as well as the European Commission's strategic postponement of the new Medical Device Regulation. Additionally, we delve into recent groundbreaking approvals encompassing two innovative oral medications for pediatric ... READ MORE >
5 things to know in life sciences: Week of June 12, 2023
This week we're tracking new COVID-19 booster strategies targeting the XBB variant, Moderna's move into mRNA therapies for rare diseases, U. S. Food and Drug Administration guidelines to safeguard tattoo inks, challenges for European medical device startups, and a Scottish startup's pilot telerobot ... READ MORE >