Nalmefene HCl Injection Now Available for Opioid Overdose Treatment
Pharmacodynamic studies have shown that nalmefene has a longer duration of action than naloxone.
Pharmacodynamic studies have shown that nalmefene has a longer duration of action than naloxone.
Imcivree is a melanocortin 4 receptor (MC4R) agonist that re-establishes MC4 receptor pathway activity to reduce hunger and promote weight loss.
The approval was based on data from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 trials, which included adults with severe alopecia areata.
The oral suspension can be administered by mouth or via feeding tube using a 5mL oral syringe that comes with the product.
Roflumilast is a highly potent and selective phosphodiesterase type 4 inhibitor.
The ADvocate 1 and ADvocate 2 trials evaluated lebrikizumab as monotherapy in patients aged 12 years and older weighing at least 40kg with moderate to severe atopic dermatitis.
Epsolay is a topical cream that utilizes a patented technology process to encapsulate benzoyl peroxide 5% within silica-based microcapsules.
The sBLA is supported by data from the phase 3 PRIME2 and PRIME trials that assessed dupilumab in patients 18 years of age and older with prurigo nodularis.
The NDA submission includes data from 2 pivotal studies that evaluated zavegepant in adults with at least a 1-year history of migraine and migraine attacks.
The THRIVE-AA1 trial included adults aged 18 to 65 years with moderate to severe alopecia areata who had at least 50% scalp hair loss.