It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations
This is Omeza’s first Rx product and the first drug/device combination matrix of its kind for chronic wound care
Invega Hafyera offers patients the fewest doses per year. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months
When used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke
First and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older
QIAreach SARS-CoV-2 antigen test, developed in collaboration with Ellume, is easy to use and provides accurate and objective results in 2 to 15 minutes
TLD is recommended by WHO, USAID, and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
Emtricitabine and Tenofovir Disoproxil Fumarate tablets had estimated annual sales of US $2.1 billion in the U.S. according to IQVIA MAT March 2021
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