MPR Weekly Dose Podcast #245 — Label Change for Opioids; Results From Weight-Loss Pill Trial; Ajovy Approved for Some Peds; Ixchiq Vaccine Restrictions Lifted; Modeyso Approved for Rare Brain Tumor
Release Date: 08/07/2025
MPR Weekly Dose
ACIP votes to change hep B vaccination for infants; positive results for retatrutide; Omisirge approved; counterfeit Ozempic seized by FDA; gene therapy approved for Wiskott-Aldrich syndrome.
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Jaypirca gains expanded approval; allograft approved to restore peripheral nerve function; baxdrostat to be reviewed as an add-on treatment for hypertension; treatment for a genetic eye disorder that causes vision loss shows promise; and an autoinjector to treat edema is accepted for Priority Review.
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Tonmya now available for fibromyalgia; safety warnings for DMD treatment; mitapivat shows mixed results in sickle cell disease trial; Redemplo approved for familial chylomicronemia syndrome; Hyrnuo approved for HER2-mutant NSCLC.
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The FDA requests boxed warnings be removed from HRT product labels; Caplyta approved for MDD; Darzalex Faspro gains new indication; investigational MS treatment looks promising; trial investigates simplified HIV regimen.
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FDA restrict the sale of unapproved fluoride products; the AAP statement on leucovorin in ASD; at-home prenatal ultrasound; Kygevvi approved; Gazyva reduces SLE disease activity.
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Label changes for tranexamic acid; new approval for Tezspire; psychedelic gains Breakthrough Tx for depression; oral semaglutide approved to reduce MACE risk in T2DM; Gazyva approved for lupus.
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New treatment approved for Bipolar I disorder; IBD treatments gain expanded approval; blood-based test for early detection of Alzheimer disease; and an oral glucagon-like peptide-1 treatment continues to show promise.
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CDC approves new immunization schedule; new treatments approved for edema, idiopathic pulmonary fibrosis, and high risk cutaneous squamous cell carcinoma; and the FDA grants Breakthrough therapy designation to a novel influenza therapy.
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New treatment approved for primary humoral immunodeficiency; eyedrops now available to improve near vision; Tremfya approval expanded to include pediatric plaque psoriasis, psoriatic arthritis; FDA fast tracks treatments for methamphetamine intoxication, Alzheimer disease.
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The CDC recommends changes to MMRV vaccine use; Trump administration claims acetaminophen linked to autism; first Barth syndrome treatment gets green light; gene therapy looks promising for Huntington disease; and a new SC formulation of Keytruda gains approval.
info_outlineClass-wide label change for opioids; positive results for oral GLP-1; migraine prevention therapy approved for children; FDA removes restriction on Ixchiq for older adults; Modeyso approved for rare brain tumor.