Merck gets fast track designation from the USFDA for anticoagulant therapy

Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis

FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations

LYNPARZA approved in the EU as adjuvant treatment for early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients

Merck updates on Phase 3 Keynote-412 trial in advanced head and neck squamous cell carcinoma

Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival in patients

Merck presents positive results from phase 1/2 study evaluating V116

V116 designed to target serotypes that account for 85% of all invasive pneumococcal disease in individuals aged 65 and over in the United States as of 2019

FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer

Acceptance based on results from the phase 3 KEYNOTE-091 trial

USFDA seeks more analysis on Merck’s BLA for Vaxneuvance

No new studies have been requested