Livalo Approved for Pediatric Patients With Heterozygous Familial Hypercholesterolemia
Livalo is indicated for pediatric patients ≥8 years old with HeFH to reduce TC, LDL-C, and Apo-B.
All articles by Brian Park, PharmD
Labeling Updated for Orbera Intragastric Balloon System to Include New Safety Data
The Food and Drug Administration (FDA) has approved updates to the Orbera Intragastric Balloon System (Apollo Endosurgery, Inc.) labeling to improve patient safety.
Additional Positive Phase 3 Data Announced for Ready-to-Use Glucagon Autoinjector
If approved, it would be the first room temperature stable liquid glucagon in an autoinjector formulation.
FDA: Arizona Company Promoting Unapproved Stem Cell Products for Lyme Disease, Diabetes, Other Serious Conditions
According to the FDA, R3 Stem Cell, LLC has marketed unapproved stem cell products to treat a variety of diseases and conditions.
Long-Term Cardiovascular Safety Data Announced for Linagliptin
Results showed non-inferiority for linagliptin vs glimepiride in meeting its primary endpoint of time to first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke.
FDA to Review Triple Combination Tablet for Type 2 Diabetes
The FDA has accepted for review the New Drug Application for an investigational triple combination tablet for the treatment of adults with type 2 diabetes.
Selective Estrogen Receptor Modulators May Be Effective for Male Infertility
Sixteen studies (controlled and non-controlled) were included in the analysis.
NDA for Twirla Contraceptive Patch Resubmitted to FDA
Agile Therapeutics has resubmitted to the Food and Drug Administration (FDA) the New Drug Application (NDA) for its product, Twirla, an investigational low-dose combined hormonal contraceptive patch (AG200-15). Based on the results from a comparative wear study, the resubmitted NDA will address the FDA’s questions on in vivo adhesion, additional information on the Company’s manufacturing…
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