Johnson & Johnson’s oral add-on drug significantly improved depressive symptoms and sleep outcomes in a phase 3 trial for patients who previously did not benefit from antidepressants alone.

To speed up drug applications, the FDA has laid out new guidance on how to request a platform designation that can smooth subsequent applications for biotechs working off the same reproducible technology.

AstraZeneca’s small molecule lowered levels of “bad” cholesterol by more than half in patients who had never received treatment for their condition, according to results from an early-stage trial.

Pulsed field ablation has been making waves in cardiac procedures in the past few months following a series of green lights among major devicemakers looking to offer treatments for atrial fibrillation and irregular heart rhythms with fewer side effects. Now, Galvanize Therapeutics is jumping in with its system that broadens the use of the tech to patients with cancer.

The FDA delivered a green light to its first closed-loop, insulin pump-controlling smartphone app that can cover pregnant women with Type 1 diabetes.

After proving the efficacy of a pertussis vaccine in preventing infection, ILiAD Biotechnologies’ next challenge was to add the shot to a Trojan horse lineup of childhood vaccines to see whether they can be co-administered.

Insmed’s medicine didn’t just reduce exacerbations of a chronic lung disease in a phase 3 trial. The drug blew the primary endpoint out of the water with “very statistically significant” results, according to analysts.

Could the IPO window really be reopening for the summer? The second biotech proposition in May seems to suggest the public markets are regaining their allure.

Innovent’s psoriasis contender to IL-23 drugs like Tremfya and Skyrizi cleared skin and improved the severity of disease in a phase 3 test, setting up the company to seek approval from Chinese regulators.

Arrowhead Pharmaceuticals’ hotly anticipated cholesterol disorder drug lowered key lipoproteins that increase the risk of cardiovascular disease in a phase 2 trial, supporting a late-stage program.