Abby Reinhard

January 26, 2022

Results from the cohort study suggest that a third dose was also associated with modestly increased levels of anti-SARS-CoV02 spike receptor-binding immunoglobulin G antibodies in those who had reduced protective humoral immunity before reimmunization.

January 25, 2022

The submission to the FDA is supported by interim data from the RAINBOWFISH trial (NCT03779334), as all 5 babies treated with risdiplam maintained the ability to swallow and feed exclusively orally after 12 months.

January 25, 2022

Investigators developed a weighted logistic regression-based sleep-wake scoring method for actigraphy data, concluding that it aided in assessing sleep in CP.

January 24, 2022

The FDA accepted the new drug application for priority review, setting a PDUFA action date of May 12, 2022.

January 23, 2022

The clinical hold comes 2 days after an announcement from Denali Therapeutics detailing a partnership with Takeda Pharmaceutical Company to codevelop and cocommercialize the treatment.

January 21, 2022

Dubbed COVID-DoC, the prospective study is the largest of its kind to date and provides initial data on the prognosis and pathophysiology of the condition in a group of patients at Massachusetts General Hospital.

January 20, 2022

The study of 251 hospitalized patients with COVID-19 found that biomarkers were elevated to levels that were similar to—or even higher than—those observed in patients with Alzheimer disease.

January 20, 2022

Yumanity Therapeutics announced the hold, which was in response to an investigational new drug application submitted to the FDA in December 2021.

January 19, 2022

The trial is a twin of ENSURE-1, which began in November 2021, and is supported by positive clinical data from the phase 2 EMPhASIS trial.

January 19, 2022

Zhittya Genesis Medicine announced the trial to evaluate its biological drug, FGF-1, which is administered via an intranasal delivery device, in a cohort of individuals with mild to moderate ALS.