US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer
The latest approval was based on the findings from the Phase II DESTINY-Lung02 trial of Enhertu.
Approvals
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Approvals
US FDA grants approval for Orion-Bayer’s Nubeqa combo for prostate cancer
The darolutamide combination treatment substantially lowered mortality risk by 32.5% in mHSPC patients.
AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer
The approval was based on findings from the Phase III DESTINY-Breast04 trial of Enhertu.
US FDA approves Pfizer-Myovant’s Myfembree for endometriosis pain
The companies will co-market the drug in the region and will be made available soon.
EC grants approval for Merck-AstraZeneca’s Lynparza for breast cancer
The approval was based on the Phase III OlympiA clinical trial of Lynparza versus placebo.
Sinovac’s Covid-19 vaccine gets approval for use in children in Hong Kong
The vaccination schedule approved for use in children aged age six months to three years is the same as those…
US FDA grants approval for Janssen’s Stelara to treat psoriatic arthritis
A completely human monoclonal antibody, Stelara hinders cytokines IL-12 and IL-23.
EC grants approval for AbbVie’s Rinvoq to treat ulcerative colitis in adults
The latest approval is based on findings from three randomised, multicentre, Phase III trials of Rinvoq.