China’s NMPA accepts GenFleet’s NDA for GFH925 to treat patients with NSCLC
The NMPA has also granted Priority Review designation to GFH925 for treating patients with advanced non-small cell lung…
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27 Nov 23
The NMPA has also granted Priority Review designation to GFH925 for treating patients with advanced non-small cell lung…
24 Nov 23
Designed to provide protection for infants throughout an entire RSV season, AK0610 has been genetically engineered from a…
23 Nov 23
The next-generation ROS1 tyrosine kinase inhibitor (TKI) is intended for use in adult patients dealing with locally advanced…
20 Nov 23
AstraZeneca secured the FDA approval based on positive results from Phase 3 CAPItello-291 clinical trial that evaluated the…
17 Nov 23
Casgevy is a genetically modified autologous CD34+ cell-enriched population that contains human hematopoietic stem and progenitor cells, edited…
17 Nov 23
The indicated use is for the initial treatment of adults diagnosed with locally advanced unresectable or metastatic human…
16 Nov 23
The approval was based on the results from the TRIDENT-1 Phase 1/2 trial in which 79% of people…
14 Nov 23
Bylvay is a once-daily, non-systemic ileal bile acid transport inhibitor, designed to act locally in the small intestine…
13 Nov 23
The approval was based on the results from two successful randomised, double-blind, active-controlled, multicentre Phase 3 trials which…
10 Nov 23
The approval was based on the totality of the evidence provided by the analysis of efficacy, pharmacokinetic, safety…