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.
Diagnosis & Disease Information
Dexamethasone Injectable Gel Fast Tracked for Lumbosacral Radicular Pain
The designation is supported by data from the phase 3 C.L.E.A.R. trial.
Zynrelef Indication Expanded to Include More Surgical Procedures
Zynrelef is a dual-acting local anesthetic that delivers a fixed-dose combination of bupivacaine and meloxicam.
Prescription Digital Therapeutic Cleared for IBS-Associated Abdominal Pain
Regulora is designed to provide seven 30-minute sessions of remote behavioral therapy based on gut-directed hypnotherapy.
Intranasal Nalmefene Fast Tracked for Opioid Overdose Treatment
The investigational intranasal formulation of nalmefene demonstrated a more rapid onset and longer duration of action compared with naloxone.
Erenumab vs Topiramate in Patients With Migraine: Head-to-Head Study Results
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.
FDA to Review Acetaminophen-Ibuprofen IV Combo for Postoperative Pain
Maxigesic is a combination of acetaminophen 1000mg and ibuprofen 300mg for IV infusion.
Celecoxib-Tramadol Combo Tablet Approved for Acute Pain
Seglentis is a co-crystal formulation of celecoxib, an NSAID, and tramadol hydrochloride, an opioid agonist and inhibitor of norepinephrine and serotonin reuptake.
Zimhi Approved for Emergency Treatment of Opioid Overdose
Zimhi is intended for immediate administration as emergency therapy in settings where opioids may be present.
Newer Pharmacotherapies Compared With Triptans for Migraine Treatment
The analysis included 64 randomized clinical trials with a total of 46,442 patients.
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