Investigation triggered by meta-analysis showing possible increased mortality in PAD patients at 2 years
Agency cannot accept new fees or applications until the shutdown is over
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
Fulphila, biosimilar to Neulasta, helps reduce risk of infection during cancer treatment.
Unapproved erectile dysfunction drugs are touted as a "healthy man alternative to the little blue pill."
NCCN recommended 47 FDA-approved drugs for 113 indications; 39% were extra recommendations
Trogarzo is given intravenously once every 14 days in combination with other antiretrovirals
Missouri-based Divinity Products Distribution will recall and destroy kratom-containing products
Agency advising doctors to consider prescribing other antibiotics to patients with coronary heart disease
Calls to poison centers regarding kratom increased 10-fold between 2010 and 2015
The FDA just approved a new short-acting insulin drug, Admelog, for patients with either T1D or T2D.
Semaglutide helps patients with diabetes reduce blood glucose levels and lower body weight.
Vabomere, which combines meropenem and vaborbactam, demonstrated superior efficacy to piperacillin/tazobactam.
The FDA is delaying implementation of last year's rules on cigars and electronic cigarettes currently on the market until 2021 and 2022, respectively.
The agency will now give priority reviews to new generic drugs until there are 3 on the market.
Amputations of the toe and middle of the foot were the most common, but leg amputations below and above the knee also occurred.
Company asks FDA to approve ferric citrate for iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease.
Noctiva is taken 30 minutes before bed and is designed to increase absorption of water through the kidneys.
The drug is indicated for treating patients with locally advanced or metastatic disease that progresses despite platinum-containing chemotherapy.
After analyzing new data, the FDA again warns that the diabetes drug may be associated with an increased risk for bladder cancer.
Renal and Urology News Articles
- Pembrolizumab Shows Promise for BCG-Unresponsive Bladder Cancer
- Radical Cystectomy Superior to Trimodal Therapy for Muscle-Invasive Bladder Cancer
- Dialysis and Transplant Patients at Increased Risk for Cancer Death
- Tivozanib Offers Superior Outcomes in Refractory Metastatic Renal Cell Carcinoma
- Radiation, Chemotherapy Not Beneficial in Localized Upper Tract Urothelial Carcinoma
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