Did RFK Jr.’s Lawyer Ask the FDA to Revoke Approval for the Polio Vaccine?
Aaron Siri, a lawyer advising Robert F. Kennedy Jr. as he prepared to become health secretary, petitioned the Food and Drug ...
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FDA-Approved IV Iron Formulations
Panelists discuss how modern FDA-approved intravenous iron formulations, including ferric carboxymaltose, ferumoxytol, and ...
FDA approves medication for sleep apnea
The U.S. Food and Drug Administration calls Zepbound the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea and obesity. The approval supports evidence ...
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FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
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FDA expands Enhertu approval to include HER2-ultralow breast cancer patients
Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...
FDA approves first-of-its-kind nasal spray for severe depression
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the ...
FDA-approved nasal spray for severe depression can lead to remission
The Food and Drug Administration (FDA) recently approved the nasal spray Spravato for the treatment of major depression in ...
Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...