The FDA has reorganized and elevated its health IT, data management and cybersecurity efforts into a single, new office that will report directly to the commissioner. The move comes as part of the agency’s wider modernization strategy as it continues to face ever-increasing amounts of clinical data.
Mutations in tumor-suppressing genes are known to drive cancer, but how? Scientists long believed that the mutations prompted the cancerous cells to grow unchecked. But a new study out of Howard Hughes Medical Institute suggests the story is more complicated than that.
A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing.
Protagonist Therapeutics’ treatment for a rare, slow-growing blood cancer is under an FDA clinical hold after the company reported safety concerns in a nonclinical mouse study.
Intellia has shown that gene editing works in the body, and now the biotech is going to try to prove the same outside of the body.
Aerie Pharmaceuticals earned the ire of Bio Twitter and investors Wednesday night after dropping a failed midstage study after-hours, then whitewashing the flop and insisting a phase 3 would go ahead anyway.
A recall of Smiths Medical’s NormoFlo irrigation fluid warmers and warming sets was characterized by the FDA as Class I, signifying a heightened risk of adverse events or death.
Biogen’s non-opioid painkiller offers mixed results in phase 2 trial, this time in sensory pain disorder
Biogen’s non-opioid pain therapy achieved mixed results between a high and low dose at reducing average daily pain during a midstage study, but patients did report an overall improvement in the pain they experience.
Amylyx can proceed with ALS submission to FDA afterall, marking a win for patients’ advocacy efforts
The FDA has done a U-turn on Amylyx’s amyotrophic lateral sclerosis (ALS) drug AMX0035. After asking for a new phase 3 study in April, the agency will now accept the biotech’s submission based on phase 2 evidence.
Zimmer Biomet has landed on a name for the upcoming spinout of its spine and dental businesses—ZimVie—and has begun filling out its C-suite ahead of the launch scheduled for the middle of next year.