After a start-of-the-year lull, activities at the U.S. Food and Drug Administration are starting to pick up, according to BioSpace.
Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) was approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration, is set to take over the top spot of the regulatory agency on an interim basis following the presidential inauguration of Joe Biden.
The U.S. Food and Drug Administration accepted for priority review a Biologics License Application (BLA) for Merck’s 15-valent pneumococcal conjugate vaccine V114.
Abbot received 510(k) clearance for the first rapid handheld traumatic brain injury (TBI) blood test, which will help clinicians assess individuals with suspected mild TBIs, including concussions.
Neoleukin was benched by the FDA with a clinical hold for the biopharma company’s lead cancer immunotherapy candidate.
DBV Technologies unveiled a global restructuring plan that will result in a reduction of more than 200 jobs.
Scientists at the National Institutes of Health and Moderna Inc. may take about two months to determine whether doses of the company’s Covid-19 vaccine can be halved to double the supply of the shots in the U.S., according to the agency.
The U.S. Food and Drug Administration warned health care personnel not to make any changes to the dosing of Covid-19 vaccines and that doing so would place the public health at risk and undermine “the historic vaccination effort to protect the population.”
Roche’s novel cancer immunotherapy tiragolumab was granted breakthrough therapy designation by the U.S. Food and Drug Administration in combination with the Swiss drugmaker’s Tecentriq in the treatment of non-small cell lung cancer.