We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
New FDA drug approvals in May include the first vaccine for respiratory syncytial virus, a hot flash treatment for menopausal women, a gene therapy for a rare skin disease and the first and only treatment for a rare hematologic disorder. Additionally, the FDA approved a next-generation sequencing-based companion diagnostic test for solid tumor profiling. Read More
Cue Health’s over-the-counter molecular nucleic acid amplification test (NAAT) for COVID-19 has been granted FDA de novo authorization, making it the first traditionally authorized at-home test for any respiratory illness. Read More
Neuralink has succeeded in winning FDA authorization to conduct a first-in-human clinical trial of its implantable brain interface after being denied in 2022 over safety concerns. Read More
The U.S. Patent and Trademark Office (PTO) has found against Longhorn Vaccines & Diagnostics for committing “egregious abuse” of the Patent Trial and Appeal Board (PTAB) process during its review of Longhorn patent claims filed against Spectrum Solutions’ COVID-19 test. Read More
The FDA has cleared several impactful devices this week — one that can predict a dangerous pregnancy complication, one that measures heart arrhythmias for up to six years after insertion just under the skin, and one that can detect the brain plaque associated with Alzheimer’s in under five minutes. Read More