alirocumab); unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's product candidates in clinical trials; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates, including without limitation Praluent, and the impact of the recommendation of the Endocrinologic
and Metabolic Drugs Advisory Committee of the U.
evaluation based on blood specimens would include thyroid function tests, gonadotropins, sex hormones and related measures, insulin resistance and glucose levels, and immunologic assessment of allergy and immune response and markers (lymphocyte subtypes) (Brouwer et al.
Her medical history included diabetes and mild hypertension, but no hematologic or endocrinologic
Now, the FDA's Endocrinologic
and Metabolic Drugs Advisory Committee was being asked to weigh in.
The current biomedical model of health care was initially dramatically successful in curing previously hopeless infectious and endocrinologic
and Metabolic Drugs Advisory Committee also noted liver and blood vessel cancers were seen in earlier tests of the drug conducted on mice.
At a meeting of the FDA's Endocrinologic
and Metabolic Drugs Advisory Committee on April 14, panelists reviewed the results of a large cardiovascular outcomes study of the dipeptidyl peptidase-4 (DPP-4) inhibitor, the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) study, an international, randomized, double-blind, placebo-controlled trial of about 5,400 people with type 2 diabetes and established cardiovascular disease.
Last month, the Endocrinologic
and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended the approval of Vimizim for the indication.
The underlying causes of HMB may be organic, endocrinologic
, anatomic, or iatrogenic (Table).
Food and Drug Administration (FDA) Endocrinologic
and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Takeda Global Research & Development (TGRD) underscores its position that ACTOS(R) (pioglitazone HCl) offers a proven safety profile regarding the risk of cardiovascular disease.
The text provides an overview of the physiologic and endocrinologic
changes and the staging of perimenopause, as well as discussions of symptom management and preventive clinical practice.
Thyroid storm is a potentially life-threatening endocrinologic
emergency characterized by an exacerbation of a hyperthyroid state.
The risk factors for nonoptimal periovulatory modulation of cervical liquefaction and oocyte maturation in humans are associated with high-risk conceptions related to compromised ovulation and/or fertilization: for example, nonoptimal maternal age and interpregnancy interval, specific seasons, endocrinologic
disturbances, inadequate diet and socioeconomic status (SES), wars and other stressors, unhealthy lifestyle, and occupational burden (33).
Orexigen reports that the Division of Metabolic and Endocrinologic
Products is planning to hold a general advisory committee on cardiovascular assessment for obesity therapeutics in 2012
today announced that the Endocrinologic
and Metabolic Drugs Advisory Committee (EMDAC) of the U.