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Exposure-response association seen between trihalomethanes and CKD risk; highest risk seen for brominated trihalomethanes.
The REMS program for the ERA drug class was established due to the risk of embryofetal toxicity seen from animal studies.
The FDA is expected to decide on treatments for bronchiectasis, chronic immune thrombocytopenia, fibromyalgia, Friedreich ataxia, and recurrent respiratory papillomatosis.
An analysis of pharmacokinetic data showed ET-600 was bioequivalent to an FDA-approved oral desmopressin product.
The reconstituted panel has not discussed RSV vaccination again and has already caused concern among doctors by questioning proven science around flu vaccines and childhood immunizations.
The lawsuit was prompted by several recent HHS actions the plaintiffs noted were “designed to mislead, confuse, and gradually desensitize the public to anti-vaccine and anti-science rhetoric.” ...
The Food and Drug Administration (FDA) has approved Ekterly ® (sebetralstat) for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.