Phathom Seeks Approval of Vonoprazan-Based Regimens for H. Pylori Infection
The applications are based on data from the phase 3 PHALCON-HP trial.
All articles by Brian Park, PharmD
Biologics License Application for Moderna COVID-19 Vaccine Submitted to FDA
The application includes data from the phase 3 COVE study that evaluated the Moderna COVID-19 vaccine in 30,420 adults 18 years of age and older.
Drug-Induced Hepatotoxicity Ends Development of Novel HBV Therapy
The phase 2 trial was evaluating the effects of ABI-H2158 in 88 treatment-naïve patients with HBeAg positive or HBeAg negative chronic hepatitis B infection without cirrhosis.
FDA Issues Marketing Denial Orders for Flavored E-Cigarette Products
The MDOs were issued to approximately 55,000 flavored ENDS products from JD Nova Group LLC, Great American Vapes, and Vapor Salon and included favors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.
AAP Advises Against Off-Label Use of COVID-19 Vaccine in Young Children
Given that the approved Pfizer-BioNTech COVID-19 vaccine dose is higher than the doses being investigated in younger children, the AAP advises against off-label use.
FDA Approves New Formulation of Gvoke for Severe Hypoglycemia
The FDA has approved the new Gvoke® Kit formulation for the treatment of severe hypoglycemia in patients with diabetes 2 years of age and older.
Pfizer Expands Chantix Recall Due to Nitrosamine Impurity
To date, the Company has not received any reports of adverse events related to this recall.
Complaint Prompts FDA Action on Use of Purple Patient Bracelets, Wristbands
The alert comes after a recent complaint about a purple wristband with a different meaning.
Welireg Approved for Cancers Associated With Von Hippel-Lindau Disease
The approval was based on data from an open-label phase 2 study which evaluated the efficacy and safety of Welireg in patients with von Hippel-Lindau-associated renal cell carcinoma and other VHL-associated tumors.
Phase 1 Data Support Booster Dose of Pfizer-BioNTech COVID-19 Vaccine
The phase 1 study is part of clinical trial program evaluating the safety, tolerability and immunogenicity of a booster dose of the Pfizer-BioNTech COVID-19 vaccine.
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