The Pharma Data

MARCH 26, 2021

It causes inflammation in the kidneys and can lead to end-stage kidney disease which may require dialysis or a transplant. 2] LN can lead to end-stage kidney disease, which requires kidney dialysis or a transplant. Approximately 20% of patients with LN progress to end-stage kidney disease within 10 years of diagnosis. [5].

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Therapies Disease Treatment Vaccine 52

The Pharma Data

MAY 5, 2021

Benlysta is the first biologic approved to treat lupus and lupus nephritis, representing a significant new treatment option for patients and physicians across Europe dealing with this complex autoimmune disease.”. 2] LN can lead to end-stage kidney disease, which could require dialysis or a kidney transplant.

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Agency IQ

APRIL 8, 2024

When the document was taken back to the drawing board again in 2003, it remained on hold for more than a decade until a final version was agreed upon in 2012, with the FDA officially adopting it in 2014. While the SRP could be used to submit information on drugs and biological products, the only exception was for vaccines.

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FDA Production Regulations Vaccine 40

Drug & Device Law

JANUARY 4, 2024

The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. To the contrary, the COVID-19 vaccine in question was fully approved by the FDA as safe and effective on August 23, 2021, and has remained so (or updated versions have) ever since.

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Vaccine FDA FDA Approval Pharmacy 59