Regulatory Updates

Latest News

FDA to Review sBLA for Jemperli for Earlier Treatment of Endometrial Cancer
FDA to Review sBLA for Jemperli for Earlier Treatment of Endometrial Cancer

June 7th 2023

The FDA has assigned an action date of Sept. 23, 2023. If approved, this would be the first frontline treatment advancement in decades for patients with advanced or recurrent endometrial cancer.

FDA Approves Prevymis for CMV Prevention in Kidney Transplant Patients
FDA Approves Prevymis for CMV Prevention in Kidney Transplant Patients

June 6th 2023

FDA Clears Lynparza for Prostate Cancer with High Mortality Risk
FDA Clears Lynparza for Prostate Cancer with High Mortality Risk

June 5th 2023

Bausch + Lomb Exec Discusses Novel Dry Eye Disease Treatment
Bausch + Lomb Exec Discusses Novel Dry Eye Disease Treatment

June 1st 2023

FDA Accepts BLA for Lifileucel for Difficult-to-Treat Melanoma
FDA Accepts BLA for Lifileucel for Difficult-to-Treat Melanoma

May 31st 2023

More News

FDA OKs first-of-its-kind treatment for paroxysmal nocturnal hemoglobinuria

FDA OKs first-of-its-kind treatment for paroxysmal nocturnal hemoglobinuria

Christine Blank
May 18th 2021

OptumRx had identified pegcetacoplan as one of the top 5 drugs in the pipeline this year.

Blockbuster Farxiga Gets New Chronic Kidney Disease Indication

Blockbuster Farxiga Gets New Chronic Kidney Disease Indication

Christine Blank
May 4th 2021

The AstraZeneca drug is the first SGLT2 inhibitor approved for chronic kidney disease regardless of whether the patient has diabetes.

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