Drug Approval | November 21, 2025
Merck receives EU nod for first subcutaneous formulation, promising faster cancer treatment
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
The new MimixTM GeniTM reference standards were developed from the extensively tested Genome-in-a-Bottle Consortium (GIAB) cell line
Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers
Kygevvi combines two pyrimidine nucleosides, doxecitine and doxribtimine, which act by integrating deoxycytidine and deoxythymidine into skeletal muscle mitochondrial DNA
Results from the Phase 2 PHAROS trial potentially establish new benchmark with targeted combination therapies for this patient population
First patients enrolled in Phase I trial with KQB548, an investigational KRAS inhibitor designed to treat KRAS G12D-mutated tumors
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company
An estimated 50% of patients with ER+, HER2– metastatic breast cancer will develop an ESR1 mutation during or after exposure to an aromatase inhibitor
Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion
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