The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza based on positive results from the pivotal PROpel trial, also published in NEJM Evidence. AstraZeneca and MSD will continue to work with the FDA as it completes its review of the application. 0.81; p<0.001). 0.81; p<0.001).

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The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application for LYNPARZA plus abi/pred for priority review based on positive results from the pivotal Phase 3 PROpel trial, which were also published in NEJM Evidence. AstraZeneca and Merck will continue to work with the FDA as the agency completes its review of the application.

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The Pharma Data

JUNE 18, 2021

Barr , M.D., Abstract EP635 ) Real-World Application of NCCN Clinical Practice Guidelines (NCCN Guidelines ® ) for CLL/SLL from the informCLL Prospective Observational Registry. 1 Barr P., “The results add to the extensive clinical evidence supporting the use of single-agent ibrutinib for long-term disease control.”

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The Pharma Data

AUGUST 22, 2021

The CHMP-endorsed PRAC recommendation is applicable to all EU member states and is in the process of being implemented in the XELJANZ summary of product characteristics. Efficacy in the juvenile PsA subtype population was consistent with polyarticular JIA. v,vi,vii. Pfizer is also continuing to work with the U.S. MALIGNANCIES.

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The Pharma Data

JUNE 16, 2021

to 0.97; p=0.04). Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications. Death from any cause through day 28 occurred in 2.8% of patients in the tofacitinib group and in 5.5%

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Pfizer

OCTOBER 28, 2022

Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications. Patients who are current or past smokers are at additional increased risk. DRUG INTERACTIONS.

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