Siklos Approval Expanded to Include Adults With Sickle Cell Anemia
The approval was based on data from the European Sickle Cell Disease Cohort study, which evaluated the efficacy and safety of Siklos in 1077 adults with sickle cell disease.
The approval was based on data from the European Sickle Cell Disease Cohort study, which evaluated the efficacy and safety of Siklos in 1077 adults with sickle cell disease.
The designation is supported by data from the phase 3 C.L.E.A.R. trial.
Zynrelef is a dual-acting local anesthetic that delivers a fixed-dose combination of bupivacaine and meloxicam.
Regulora is designed to provide seven 30-minute sessions of remote behavioral therapy based on gut-directed hypnotherapy.
The investigational intranasal formulation of nalmefene demonstrated a more rapid onset and longer duration of action compared with naloxone.
The HER-MES trial included 777 adults with episodic or chronic migraine (at least 4 migraine days/month) who were treatment-naïve, not suitable for, or had previously failed up to 3 prophylactic migraine treatments.
Maxigesic is a combination of acetaminophen 1000mg and ibuprofen 300mg for IV infusion.
Seglentis is a co-crystal formulation of celecoxib, an NSAID, and tramadol hydrochloride, an opioid agonist and inhibitor of norepinephrine and serotonin reuptake.
Zimhi is intended for immediate administration as emergency therapy in settings where opioids may be present.
The analysis included 64 randomized clinical trials with a total of 46,442 patients.