AbbVie Seeks Approval of Risankizumab for Crohn Disease
The application is supported by data from two phase 3 induction studies (ADVANCE and MOTIVATE) and one phase 3 maintenance study (FORTIFY).
Gastroenterology
Long-Acting Octreotide Therapy Gets Orphan Drug Status for Polycystic Liver Disease
CAM2029 is an investigational ready-to-use, long-acting octreotide subcutaneous injection depot.
AbbVie Seeks Approval of Upadacitinib for Ulcerative Colitis
The applications are supported by data from two 2two phase 3 induction studies and one 1 maintenance study.
Tislelizumab Under Review for Esophageal Squamous Cell Carcinoma
The application is supported by data from the phase 3 RATIONALE 302 trial.
Phathom Seeks Approval of Vonoprazan-Based Regimens for H. Pylori Infection
The applications are based on data from the phase 3 PHALCON-HP trial.
Recall of Amino Acid Injection Initiated Due to Visible Particulate Matter
Though acquired by ICU Medical, the affected product contains a Hospira NDC number and label.
Pharmacotherapies for Liver Fibrosis, NASH Resolution Ranked
Although NASH is a common cause of chronic liver disease, there is limited evidence surrounding its management.
PPI Use May Increase Risk of Community-Acquired Pneumonia
Increased incidence of CAP was noted in stroke patients using PPIs.
Vazalore Liquid-Filled Aspirin Capsules Now Available Over the Counter
Vazalore™, a liquid-filled aspirin capsule, has been made available by PLx Pharma. Vazalore was approved by the Food and Drug Administration in March 2021. It is indicated for patients with vascular disease and those with rheumatologic diseases who are candidates for aspirin therapy. The product is designed to improve the absorption of aspirin by targeting…
Linzess Labeling Updated Based on New Pediatric Data
The updated label now states that the treatment is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.
