News
The approval was based on data from the phase 3 ARASENS trial.
News
The FDA has approved Kyzatrex (testosterone undecanoate) for the treatment of primary and secondary hypogonadism in adult males.
Safety Alerts and Recalls
The products were being promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores.
News
The approval was based on data from a phase 4 study which included patients 12 to 17 years of age with a BMI at the 95th percentile or greater standardized for age and sex.
News
Pharmacodynamic studies have shown that nalmefene has a longer duration of action than naloxone.
Drugs in the Pipeline
The PRECISION study included adults with uncontrolled blood pressure despite at least 3 background antihypertensive medications.
News
The approval was based on data from a phase 3 study that compared Voquezna Triple and Dual Pak with lansoprazole plus amoxicillin and clarithromycin.
Drugs in the Pipeline
The SURMOUNT-1 trial evaluated tirzepatide as an adjunct to a reduced-calorie diet and increased physical activity in adults without type 2 diabetes who have obesity or are overweight.
Safety Alerts and Recalls
Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
Drugs in the Pipeline
The phase 3 REDWOOD study included patients aged 30 years and older with primary autonomic failures and symptomatic neurogenic orthostatic hypotension.