Drug Approval | August 20, 2022
DCGI approves AstraZeneca 's Olaparib film-coated tablets
Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer
Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast 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
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients
This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant.
The study demonstrated that patients who received NONS had significant reduction in viral load within 24 hours, which was sustained over seven days of treatment.
An interim analysis of this data shows no significant safety issues and a 91% seroconversion rate at Day 56.
Acceptance based on results from the phase 3 KEYNOTE-091 trial
Tislelizumab is now approved in nine indications in China
Based on a post hoc analysis, fewer required respiratory interventions
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