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January 30, 2025: “The U.S. The most common adversereactions in study participants who received Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash.
to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 16] Even more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! From indoor pollutants like formaldehyde (yes, really!),
Common adversereactions included gastrointestinal issues, with a low discontinuation rate due to adverse drug reactions. The CRL was received after OLC’s initial Prescription Drug User Fee Act date of June 28, 2025, and cited for deficiencies that are unrelated to OLC itself. June 30, 2025. News release.
3 The safety profile was favorable with the most common adverse effect (AE) being increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.
Authored By: Aneeka Chavda, MRPharmS, MSc, MCMI, PgDipClinPharm Posted 19 June 2025 Mycobacterium tuberculosis (TB ) is one of the leading causes of death globally. Finally, the use of fluoroquinolones are discussed, especially for drug-resistant or intolerant patients, noting their potential in CNS TB and as part of shorter-course therapies.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for August 31, 2025. The BLA submission is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modelling of observed data. Eisai holds final decision-making authority.
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