FDA: Fluoroquinolones Tied to Heart Vessel Ruptures, Tears
Patients at risk include those with hypertension or certain genetic disorders and the elderly
Patients at risk include those with hypertension or certain genetic disorders and the elderly
Prior to starting Xyosted, the patient’s baseline cardiovascular risk should be considered and blood pressure should be adequately controlled.
Revised process will ensure new medical devices meet safety and effectiveness standards
Reports include chest pain, severe headaches, prolonged erections after taking Rhino products.
Drug targets solid tumors with NTRK gene fusion without a known acquired resistance mutation
All lots of non-expired products that contain valsartan supplied by Zhejiang Huahai being recalled.
Pivotal trials supporting these approvals often lack randomization, double-blinding, control groups.
This latest approval now makes enzalutamide the only FDA-approved oral medication indicated for both metastatic and nonmetastatic castration-resistant prostate 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).
Half of meds ID’d in expanded access programs treat cancer; others for metabolic, endocrine diseases