The clinical trial will evaluate the safety, tolerability and pharmacokinetic properties of ICP-723 in patients with solid tumours, and evaluate the anti-tumour efficacy of ICP-723 on NTRK fusion-positive cancers
The drug is also intended for the treatment of glioblastoma multiforme
The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
The Evolut FX TAVR system is used for treatment of symptomatic severe aortic stenosis and it has features that enhance ease-of-use and predictable valve deployment
New treatment options are critical, as approximately half of all people with heart failure die within five years of diagnosis. Heart failure accounts for more than one million hospitalisations a year in the US
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
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