Approvals
After receiving daily doses of the therapeutic, 71% of the children could tolerate the equivalent of 16 peanuts and six months later, 21% of them still could.
The FDA has lifted the partial hold on Kura Oncology’s KOMET-001 Phase IB trial on a potential treatment for acute myeloid leukemia.
Expanded approval for Rinvoq was based on three Phase III studies that included more than 2,500 patients. The studies met all primary and secondary endpoints.
The approval of Cibinqo was based on data from five clinical trials of more than 1,600 people. Safety and efficacy were studied in three Phase III trials.
Researchers from the Medical University of Bialystok in Poland identified a gene that appears to double the risk of severe COVID-19.
Denali Therapeutics announced that the FDA had placed a clinical hold on the IND application for DNL919 and would receive an official clinical hold letter from the agency in about 30 days.
While Biocon intends to address the CRL, the company has not established a timeline for the resubmission of data and hopes that the FDA will rapidly review the BLA when it does submit the data.
The approval was based on data from a broad clinical program of 1,854 adults with insomnia conducted at more than 160 clinical sites in 18 countries.
The U.S. averages more than 700,000 new COVID-19 cases per day. As of Saturday, there were 4.91M cases, more cases in seven days than in April, May, June, and July 2021 combined.
Biopharma companies are building momentum to carry them through the bulk of 2022. BioSpace takes a look at some of the recent announcements.
PRESS RELEASES