FDA lifts hold on Rocket Pharma's gene therapy trial
Rocket will also collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort
Rocket will also collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort
The randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants
OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors
The company reported revenue from operations at Rs. 6,573.7 crore, up 6 per cent YoY
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA
Tamsulosin, an alpha-1 adrenergic receptor blocker, combined with Dutasteride, a dual 5- alpha-reductase inhibitor, is indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) in adult men
Treatment with the selective NaV1.8 pain signal inhibitor VX-993 after bunionectomy surgery did not meet the primary endpoint
The submission is supported by results from the Phase 3b APEX study
The performance was below anticipated levels, primarily due to external factors such as seasonal disruption that affected overall results
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