The U.S. Food and Drug Administration issued a partial clinical hold for Foghorn Therapeutics’ Phase I clinical study, investigating the safety and efficacy of FHD-286 in patients with relapsed and/or refractory acute myelodysplastic leukemia (AML) and myelodysplastic syndromes (MDS). The hold follows a serious adverse event in which a study participant died after developing possible differentiation syndrome.
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Aptamil maker Danone SA stepped up shipments of infant formula from Europe to address a shortage in the United States, according to U.S customs data and an analysis of ocean cargo data by shipping consultancy Ocean Audit for Reuters.
Pharmaceutical companies including Novartis and Roche have teamed up with global cancer organizations in an alliance aimed at getting more oncology medications to poorer countries.
The U.S. Centers for Diseases Control and Prevention (CDC) on May 19 said reports of heart inflammation linked to the Pfizer/BioNTech COVID-19 vaccine have been much lower in 5- to 11-year-old boys than in adolescents and young men, representing only a slightly elevated rate than normal.
The U.S. Food and Drug Administration announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications.
A man in Massachusetts became the first person reported to have a case of monkeypox in the United States since 2021. The man contracted monkeypox after traveling to Canada, although Quebec’s Ministry of Health and Social Services told CBC News that no cases had been reported to the agency. SIGA Technologies is prepared to provide treatment to those infected with monkeypox.
There appears to be a rise in COVID-19 illnesses, driven by Omicron subvariants, which may be better able to evade immunity from vaccines and previous infections and lower public health measures by the public such as masking and social distancing.
Abbott Laboratories and the U.S. Food and Drug Administration are on track to reopen the company’s Sturgis, Michigan, baby formula manufacturing plant within one or two weeks, FDA Commissioner Robert Califf said on May 19.
A smattering of monkeypox cases in Britain prompted authorities to offer a smallpox vaccine to some healthcare workers and others who may have been exposed, as a handful more cases were confirmed in parts of Europe.
An advisory panel to the U.S. Centers for Disease Control and Prevention (CDC) is meeting on May 19 to discuss whether to recommend COVID-19 vaccine booster shots for children ages 5 to 11, a group that is just 29% vaccinated so far.