Drug Approval | November 08, 2025
Zydus Lifesciences secures FDA tentative approval for Olaparib tablets
Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers
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
New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations
The therapy delivers the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations
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