Drug Approval | June 17, 2024
Imfinzi approved in the US for endometrial cancer
Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy
Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy
First and only BTK inhibitor to demonstrate favourable overall survival trend vs. standard-of-care chemoimmunotherapy in this setting
The HD21 study adds to the body of evidence supporting ADCETRIS as a backbone agent in the treatment of specific lymphomas
First BTK inhibitor to show favourable trend in overall survival vs. standard-of-care chemoimmunotherapy in this setting
GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)
TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer
First and only immunotherapy to demonstrate survival benefit in this setting in a global Phase III trial
Application based on results from the TROPION-Breast01 Phase III trial
Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
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