FDA: Fluoroquinolones Tied to Heart Vessel Ruptures, Tears
Patients at risk include those with hypertension or certain genetic disorders and the elderly
FDA
Xyosted Now Available for Treatment of Testosterone Deficiency
Prior to starting Xyosted, the patient’s baseline cardiovascular risk should be considered and blood pressure should be adequately controlled.
FDA to Update Medical Device Approvals Process
Revised process will ensure new medical devices meet safety and effectiveness standards
Men Should Avoid ‘Rhino’ Sexual Enhancement Products, FDA Says
Reports include chest pain, severe headaches, prolonged erections after taking Rhino products.
FDA Approves Vitrakvi for Cancers With Certain Genetic Trait
Drug targets solid tumors with NTRK gene fusion without a known acquired resistance mutation
FDA Recalls Drugs Containing Active Ingredient Valsartan
All lots of non-expired products that contain valsartan supplied by Zhejiang Huahai being recalled.
Trials Supporting FDA Approval of Breakthrough Drugs Examined
Pivotal trials supporting these approvals often lack randomization, double-blinding, control groups.
FDA Approves Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer
This latest approval now makes enzalutamide the only FDA-approved oral medication indicated for both metastatic and nonmetastatic castration-resistant prostate cancer.
Keytruda, Tecentriq Labeling Updated to Limit Use in Urothelial Cancer
The updates come after the Agency made the decision to limit the use of these agents as monotherapy in patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).
Many Drugs Made Available Via FDA Expanded Access Programs
Half of meds ID’d in expanded access programs treat cancer; others for metabolic, endocrine diseases
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