Yusimry, a Humira Biosimilar Product, Gets FDA Approval
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
All articles by Brian Park, PharmD
Maintenance of Clinical Remission Observed With Mirikizumab in Ulcerative Colitis Trial
LUCENT-2 is a maintenance study evaluating the efficacy and safety of mirikizumab in patients who achieved clinical response in the 12-week LUCENT-1 induction study.
Zepatier Approval Expanded to Include HCV Treatment of Pediatric Patients
The approval was based on data from a phase 2b study which evaluated Zepatier in 22 patients aged 12 to less than 18 years.
Clinical Remission, Endoscopic Response Seen With Upadacitinib in Crohn Disease Trial
Over 60% of the study participants had previously failed 2 or more biologic therapies.
Rinvoq Labeling Updated to Include Class Warnings Related to JAK Inhibitors
The update follows the FDA’s Drug Safety Communication, which was based on a completed review of a large randomized safety clinical trial evaluating tofacitinib in patients with rheumatoid arthritis.
Two Lots of COVID-19 Antiviral Drug Veklury Recalled
Veklury is indicated for the treatment of COVID-19 in patients aged 12 years and older (weighing at least 40kg) requiring hospitalization.
PreHevbrio, a 3-Antigen Hepatitis B Vaccine, Gets FDA Approval
PreHevbrio contains the small (S), middle (pre-S2) and large (pre-S1) hepatitis B surface antigens.
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.
Cyclophilin Inhibitor Fast Tracked for Nonalcoholic Steatohepatitis
In preclinical studies, CRV431 has been shown to reduce liver fibrosis and hepatocellular tumor burden.
Additional Data Support Efficacy of Molnupiravir for Mild to Moderate COVID-19
The phase 3 MOVe-OUT trial included all 1433 at risk adults with mild to moderate COVID-19 and symptom onset within 5 days of randomization.
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