New Dosing Regimen Approved for Erbitux in Colorectal, Head and Neck Cancer
The new dosing schedule is in addition to the approved weekly dosage regimen.
All articles by Brian Park, PharmD
Upadacitinib Meets End Points in Ulcerative Colitis Trial
The U-ACCOMPLISH induction study evaluated the efficacy and safety of upadacitinib in 515 adults with moderate to severe ulcerative colitis.
Maralixibat Gets Priority Review for Cholestatic Pruritus in Alagille Syndrome
Maralixibat is an oral apical sodium dependent bile acid transporter (ASBT) inhibitor.
EndoClot PHS Approved to Control Bleeding During GI Procedures
EndoClot PHS is a single-use device consisting of a starch-based powder hemostat to control bleeding in the GI tract.
Humira Approved for Pediatric Ulcerative Colitis
The pediatric approval was based on data from the multicenter, randomized, double-blind phase 3 ENVISION I study.
FDA: Certain Factors May Affect Pulse Oximeter Accuracy
According to the FDA’s safety communication, multiple factors may affect the accuracy of pulse oximeter readings, including poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish.
Bamlanivimab Promising for COVID-19 Prevention in Long-Term Care Facilities
The placebo-controlled BLAZE-2 trial included 965 adults who tested negative for SARS-CoV-2 at baseline (299 residents and 666 staff) in the primary analysis for assessing prevention.
Ozanimod Gets Priority Review for Ulcerative Colitis
The submission is supported by data from the True North trial that assessed ozanimod as an induction and maintenance therapy for adults with moderately to severely active UC who had an inadequate response to prior treatment.
Retifanlimab Under Review for Anal Squamous Cell Carcinoma
The BLA is supported by data from the POD1UM-202 trial that evaluated retifanlimab in 94 adults with locally advanced or metastatic SCAC who progressed after platinum-based chemotherapy.
FDA to Review Additional GI Cancer Indications for Nivolumab
The sBLA submissions were based on data from the CheckMate -649 and CheckMate -577 trials.
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