FDA grants accelerated approval to Zongertinib for HER2-mutated non-squamous NSCLC
New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations
New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations
The trial is the largest to date evaluating Leqvio and the first to focus on patient-centered outcomes
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
The positive benefit-risk profile of vericiguat in its approved indication in patients with HFrEF following a recent heart failure event based on the pivotal Phase III VICTORIA trial remains unchanged
Treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefit
WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals
Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya
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