BioMarin’s shares plummeted in early Wednesday trading after the FDA refused to approve its hemophilia A gene therapy valoctocogene roxaparvovec.

As science rapidly accelerates to address COVID-19 and other disease indications, we can’t lose sight of the importance of regulatory guidelines and requirements that ensure the safe, ethical treatment of patients participating in research studies.

Six months after netting the FDA’s green light for its groundbreaking portable MRI machine, Hyperfine Research has secured a second clearance for a newer generation of the device.

Oncology studies were some of the hardest hit in the first few months of the pandemic, but more than a third have now resumed.

NEW YORK & WALTHAM, Mass.- — Bristol Myers Squibb (NYSE: BMY) and Dragonfly Therapeutics, Inc. (“Dragonfly”), today announced that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted the global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine DF6002. DF6002 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses.

CAMBRIDGE, Mass.,  — Neuroptika, a privately held biotechnology company focused on the development of novel regenerative treatments for ophthalmic diseases, today announced completion of enrollment in a Phase 2 clinical controlled, double-masked trial of NRO-1 for the treatment of patients with dry eye disease. NRO-1 is a novel therapeutic with the potential to regenerate corneal nerves in ophthalmic diseases.

According to a clinical study funded by the National Institutes of Health, multifocal contact lenses were able to slow down and control the worsening of nearsightedness in children.

The cell-signaling molecule interleukin-2 (IL-2) plays two very distinct roles in the immune system. It’s capable of either activating or containing inflammatory responses, depending on which cells predominantly respond to its signaling.

RapidAI has secured an FDA clearance for its artificial intelligence algorithms that quickly parse brain CT scans and spot suspected large vessel occlusions, the cause of fatal or debilitating strokes.

The FDA has handed Scholar Rock a rare pediatric disease designation voucher, which can allow the biotech a speedy review of its leading of spinal muscular atrophy (SMA) hopeful SRK-015.