A pair of recalls of devices made by Germany’s Dräger Medical and U.K.-based NOxBOX have each been given the FDA’s most serious Class I rating, the agency announced in separate notices this week.

Three women are suing the cancer blood test developer Grail claiming that, during their time as high-level sales employees, they suffered harassment, discrimination and ultimately retaliation under “a fraternity house” type of toxic work culture led by senior staff.

A safety signal has derailed Theseus Pharmaceuticals’ quest to develop a gastrointestinal stromal tumor (GIST) treatment. The dose-limiting toxicity drove the biotech to stop enrollment and end development, sending its stock down 65% and leaving its hopes of navigating the R&D maze resting on other assets.

Caribou Biosciences CEO Rachel Haurwitz, Ph.D., has nothing but praise for the autologous CAR-T cell therapies that have provided another option for lymphoma patients. It’s just that her CRISPR gene editing company would like to do it better with an off-the-shelf approach.

Sirona is not beating around the bush: the company has had a difficult time selling its diabetes med and is now “less confident” it will score a licensing deal.

After more than four years of scientific review, the FDA is rolling back warnings over cardiovascular devices and implants coated with the drug paclitaxel, saying studies have shown they do not carry an excess added risk of early death.

With cases of arrhythmia and heart disease on the rise—thanks in large part to an aging global population—more tools and technologies are needed to speed up the process of diagnosing and beginning treatment for these and other heart conditions.

ObsEva has resecured the China rights to its pregnancy drug after Yuyuan BioScience allegedly failed to hit pre-agreed milestones on time.

Swiss pharma giant Novartis welcomed new collaborators to its Beacon of Hope initiative focused on expanding clinical trial inclusion and medical care for underserved patient populations.

First Wave BioPharma’s bid to challenge AbbVie for a gastrointestinal market has suffered a setback, with the biotech telling investors “it is likely the primary efficacy endpoint was not achieved.”