FDA Updates

Recent approval under new international Project Orbis.

Ultra-rare, potentially life-threatening genetic disease.

Hemoglobin S Polymerization inhibitor oral treatment.

Approved for patients 18 years of age and older

Antibiotic with a novel penetrative mechanism.

Expected U.S. launch in 2023.

First and currently only biological targeting P-selectin.

MCL is an aggressive form of NHL

Shown to reduce regular RBC transfusions in adults with beta thalassemia.

Approved for ages 65 and older.

First and currently only rifabutin-based H. pylori therapy approved.

Delayed-release oral capsules for various forms of the disease.

Commercial launch suspended due to manufacturer liquidity.

New formulation improves safety for patients.

Previously approved for IV infusion.

Fourth indication expansion for the 2009 drug.

Reduces risk for heart failure and cardiovascular disease hospitalizations.

Drug able to treat 18,000 people will cost over $300k per year.

Available for prescribing starting January 2020

First approved in 2018 for patients 12 years of age and older.

Originally approved in 1995 for use in adults only.

Administered via a once-daily transdermal patch.

New CGM eliminates fingersticks, introduces new data presentation.

Afamelanotide released through subcutaneous implant.

Also indciated to control bleeding and perioperative management.

Injection for leading cause of severe vision loss and legal blindness.

First new treatment of its kind in over 20 years.

For granulomatosis with microscopic polyangiitis in children.