The FDA has provided yet another twist in the Iovance Biotherapeutics saga. After years of delays, the biotech was on track to receive an approval decision on its tumor-infiltrating lymphocyte (TIL) melanoma therapy this year only for the FDA to delay the deadline because of “resource constraints.”
As White House mulls microbe research, microbiologists chime in with calls for standardized practices
Scientists with the American Society for Microbiology, or ASM, called for standardized practices, greater public transparency and more in a new report on gain-of-function research, studies where microbes are given characteristics that don’t exist in nature and, in some cases, could make them more dangerous.
As the TIGIT class gets closer to finally seeing clinical success, Bristol Myers Squibb is trimming one of its candidates.
Mammogram AI shows more promise, performing as well as radiologists in breast cancer screening study
A study of mammograms taken of more than 55,000 women found that an artificial intelligence program could potentially serve as a backup set of computerized eyes when searching for the signs of breast cancer.
Sanofi has handed First Wave BioPharma a chance to reposition a long-dormant molecule. The biotech is paying $500,000 upfront for capeserod as part of a deal that gives Sanofi the right of first refusal to buy the asset back.
Four years ago, when NeurAxis was still known by its founding name, Innovative Health Solutions, it earned an FDA de novo clearance for the IB-Stim device as a neuromodulation treatment for teenagers experiencing pain associated with irritable bowel syndrome.
Image-guided robotic procedures have taken large steps forward in recent years, but one area where they have yet to make inroads is MRI, the tool of choice for scanning soft tissue. The dangers of introducing any extra objects to a strong, fluctuating magnetic field are obvious, and when combined with a cramped working space, the entire prospect poses significant obstacles.
Just days after a CEO shake-up, Madrigal Pharmaceuticals has shared that the FDA has given its nonalcoholic steatohepatitis (NASH) drug priority review and that the agency doesn’t plan on holding an advisory committee meeting.
We already have GPS systems to guide us through busy streets, golf courses, sprawling academic buildings and big box stores—so why not the human body?
Clinical development and analytics provider Phesi in partnership with Krystelis has launched a new service to recruit more diverse patients in clinical trials.