The primary end point was radiographic progression-free survival (rPFS), defined as the time from randomization to radiographic disease progression at any time or death within 24 weeks after drug discontinuation.
Some lots of losartan contaminated with the cancer-causing chemical N-methylnitrosobutyric acid
Proportion of apical procedures using transvaginal mesh decreased in year after safety communication
The FDA has concluded that the use of entacapone to treat Parkinson disease (PD) does not increase the risk of developing prostate cancer.
The agency alleges manufacturers failed to provide evidence of the long-term safety of surgical mesh for transvaginal repair of anterior compartment prolapse.
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