Some 300 biotech executives and industry leaders are objecting to the decision from a Texas federal judge to block the FDA’s approval of abortion drug mifepristone. The executives argue that the judicial interference will undermine the agency’s authority and endanger innovation in the industry.

In a classic “two steps forward, one step back” situation, just as Philips is aiming to wrap up the repair-and-replace program for the 5.5 million respiratory devices it began recalling two years ago, the company has had to double back and re-recall a slew of the already repaired machines.

A cell has to know what it is to do its job. New research from Trinity College Dublin has helped reveal just how cells establish their identities, which could have implications for developing more targeted cancer treatments.

Current diabetes risk assessments—including the American Diabetes Association’s 60-second risk test for Type 2 diabetes—typically take only a handful of basic, surface-level information into account: age, gender, race, family history and activity levels, among others.

Sernova, developer of a insulin-producing cell pouch implant to help treat diabetes, is fending off a proxy battle from a group of investors that says the company’s leadership has shown slow progress in clinical trials and presided over sliding stock value.

Takeda is moving away from early-stage R&D work in adeno-associated virus-based gene therapies and the rare hematology spaces, with an unknown number of employees set to “transition out” of the pharma.

After reversing course on a SPAC deal last year, cardiac diagnostic developer HeartFlow has picked up what could hardly be considered a consolation prize.

More than a decade after it first became available to help patients hospitalized with spinal cord injuries breathe more naturally than they can with a ventilator, Synapse Biomedical’s diaphragm pacing system is, fittingly enough, picking up the pace.

ConcertAI, which specializes in software and real-world evidence for clinical trials, has unveiled the latest version of its clinical trial optimization product.

How exactly are baby human adenoviruses born? Scientists have wondered about this question for a long time, and new research published this week in Nature revealed the process that viral proteins use to replicate—which could lead to better gene therapy delivery and other new therapeutics.