The U.S. Food and Drug Administration approved Gilead Sciences’ antiviral therapy Veklury (remdesivir) as the first treatment for COVID-19 in young children.
ReutersAxsome Therapeutics said on April 25 the company expects the U.S. health regulator to decline approval for the drug developer’s treatment of acute migraine over unresolved issues of its quality control processes, sending shares of Axsome down 20 percent.
Novavax shared positive initial results from the Phase I/II clinical study of the company’s proposed combination vaccine for COVID-19.
ReutersModerna plans to submit an application to the U.S. health regulator for emergency use authorization (EUA) of the company’s COVID-19 vaccine among kids between the ages of six months to five years by the end of the month, a company spokesperson said.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
AbbVie terminated the company’s collaboration agreement with BioArctic in the development of alpha-synuclein antibodies for Parkinson’s disease and other movement disorders.
Getty ImagesEli Lilly is facing $165 million in charges and development milestones from the U.S. Securities and Exchange Commission (SEC). The charges come from several in-process research and development projects acquired outside of a business combination.
The U.S. Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food allergens identified by law in the United States (non-listed food allergens).
McKinsey & Company, a consulting firm that covers multiple industries including healthcare and life sciences, is under fire for allegedly allowing its employees to work simultaneously for big pharma companies and serve as consultants for the U.S. Food and Drug Administration.
The U.S.Food and Drug Administration granted Emergency Use Authorization (EUA) for a breathalyzer that can detect COVID-19 within three minutes.
