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New Drug Designations - August 2023

New Drug Designations – August 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices  Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…

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New Drug Designations - July 2023

New Drug Designations – July 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, China, and Korea. This month’s report includes 7 biological drugs, 10 small molecules, 8 cell and gene therapies, 1 radiopharmaceutical, 2 microbiota and 1 diagnostic test  MyoPax’ Satori-01, focused on repairing the Exstrophy-Epispadias Complex sphincter…

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Disease of the Month: AIDS

Disease of the Month: AIDS

“Putting Ourselves to the Test: Achieving Equity to End HIV”  -Theme of the year 2022  Introduction: HIV/AIDS is one of the top 10 cause of mortality. It is a chronic, epidemic disease caused by human immunodeficiency virus (HIV), a virus that infect WBC’s CD4 T-cell of the immune system. HIV, a type of retrovirus that isn't…

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Top Performing Drug of 2021 – Eylea (September Edition)

Top Performing Drug of 2021 – Eylea (September Edition)

Active Ingredient: Aflibercept Strength: 2 mg (0.05 mL) Dosage Form: Injection (intravitreal) Mechanism of Action: VEGF-A and PlGF inhibitors First Approval: US (18 Nov 2011), EU (27 Nov 2012) Revenue1 EYLEA net sales represent a significant portion of the total revenues for both Regeneron and Bayer. Both companies jointly commercialize the product Regeneron records net product sales of EYLEA in…

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