Nuzyra, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains.
The NDA is supported by data from the Phase 3 ENLIVEN study (N=120) which randomized patients with symptomatic TGCT to receive pexidartinib or placebo to evaluate the safety and efficacy of the treatment.
Alyq should not be used with concomitant organic nitrates or guanylate cyclase (GC) stimulators (eg, riociguat), and in patients with a known serious hypersensitivity to tadalafil.
To investigate the effectiveness of compounded creams in the treatment of chronic pain conditions, study authors performed a double-blind, randomized, parallel study comparing creams compounded with an active ingredient to placebo creams.
The patient had a history of asthma, COPD, diabetes and severe anaphylactic reactions to multiple medicines.
The ACIP and CDC have approved and released 2019 recommendations for the adult immunization schedule in the US.
Both filings have been granted Priority Review by the Agency.
In preclinical models, the inhibition of phosphorylated STAT3 (p-STAT3) by WP1066 resulted in the direct attack of various tumor cells.
While the exact mechanism of action of cenobamate is not fully understood, it is believed to work through a dual mechanism.
It is designed to release fluocinolone acetonide, a corticosteroid, at an initial rate of 0.25mcg/day.