Roche has secured an approval in Europe for its artificial-intelligence-powered continuous glucose monitoring system with a green light for adults with Type 1 or Type 2 diabetes that rely on real-time readings to adjust their insulin doses.

The clinical journey for uniQure’s Huntington’s disease gene therapy got off to a bumpy start, but now the company says the latest interim data shows a slowing of disease progression.

Mikael Dolsten, M.D., Ph.D., ⁠told Fierce Biotech back in February that his professional approach is to be “open to change.” Now, after 15 years at Pfizer, including a career-defining pandemic period, the chief scientific officer will leave the Big Pharma once the drugmaker finds his successor.

After developing its pulsed field ablation technology for use outside cardiology, Pulse Biosciences has now received a boost from the FDA with a breakthrough designation to help adapt its approach to treat irregular heart rhythms.

Keytruda has beaten Roche’s TIGIT drug candidate at the first interim analysis of a phase 2/3 lung cancer trial, prompting the Swiss drugmaker to stop the study and consider changes to the broader program.

HilleVax’s stock took a nosedive after the vaccine biotech’s sole clinical-stage candidate failed a phase 2b trial in norovirus-related acute gastroenteritis (AGE).

Organ transplant preservation company Paragonix Technologies is launching the first FDA-cleared system for protecting donated pancreas tissue.

Roche has filed a lawsuit against Stanford University and its spinout Foresight Diagnostics, saying the young cancer test developer was built upon trade secrets it acquired for detecting tumor DNA in the bloodstream.

Radiopharmaceutical company Pentixapharm is picking up fellow Germany-based Glycotope’s target discovery unit for an undisclosed sum in order to double its pipeline courtesy of a portfolio of preclinical cancer antibodies.

The FDA has greenlit its first point-of-care diagnostic test for hepatitis C, capable of using only a fingerstick blood sample, in a bid to quickly connect patients with antiviral drugs.