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
Therapy recently approved in Canada under the brand name KORSUVA
The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
Phase 1 dose-escalation study to be conducted at clinical sites in the U.S., the UK, Australia, and the Philippines
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
The study concluded that elevated levels of two proteins help predict how a person will recover from a traumatic brain injury (TBI), providing important information to determine appropriate care
Collaboration supports multiple discovery efforts, including vaccines
Collaboration focuses on developing and implementing real-world research to drive patient access to cancer medicines
All claims made by Seagen regarding Daiichi Sankyo antibody drug conjugates are denied
Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age
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