In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
FDA and EMA both approve additional biosimilar versions of Humira® (adalimumab). FDA also approves its third biosimilar version of Neupogen® (filgrastim). ...more
FDA and EMA both approve first biosimilar version of Lucentis® (ranbizumab). FDA has approved only two biosimilars in 2021 after only approving three in 2020. EMA approves four more Avastin® (bevacizumab) biosimilars,...more