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The House Appropriations Committee is scheduled to mark up a fiscal 2023 FDA funding bill on Thursday that includes a 10 percent increase for the agency. Read More
On the heels of unanimous recommendations last week by its vaccines advisory committee, the FDA granted Emergency Use Authorization (EUA) on Friday for Moderna’s COVID-19 vaccine for children between six months and 17 years and for Pfizer-BioNTech’s COVID-19 vaccine for children between six months and four years. Read More
The Federal Trade Commission (FTC) has warned drugmakers and pharmacy benefit managers (PBM) that it will be stepping up enforcement of alleged illegal bribes and rebates that hinder patient access to cheaper drugs. Read More
After endeavoring to do so throughout much of the pandemic, the World Trade Organization (WTO) has reached an agreement that allows developing countries to produce their own generic versions of COVID-19 vaccines. Read More
Roche is finally throwing in the towel on crenezumab, the antiamyloid antibody researchers hoped might prevent the disease in a group of South American families genetically destined to develop it at a very young age. Read More
Acadia is having another go at Nuplazid (pimavanserin), hoping to convince the FDA’s Psychopharmacologic Drugs Advisory Committee that the antipsychotic should win a new indication as a treatment for dementia-related hallucinations and delusions. Read More
As global cases of monkeypox continue to increase, the World Health Organization (WHO) is recommending two smallpox vaccines for off-label use against monkeypox and one that has been approved for prevention of monkeypox. Read More
The Supreme Court unanimously ruled that the Department of Health and Human Services (HHS) can’t reduce its payment rates for only a certain group of hospitals — namely, 340B Drug Discount Program hospitals — without first conducting a survey of hospitals’ acquisition costs for each covered outpatient drug. Read More