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CF, a rare and life-shortening genetic disease, that affects around 75,000 people across the globe. It is a progressive and multi-system disease that damages the lungs, liver, GI

With this validation, the application is complete, and the EMA will now begin the review procedure. Tepotinib is a highly selective oral MET inhibitor that is administered once

The first-in-human trial initiated last year in healthy adults studied single and multiple doses of NaQuinate. The primary objective was to assess the safety, tolerability and pharmacokinetics. ”We

1n 2019, Astellas and FibroGen have also received Japanese approval for roxadustat for the treatment of anaemia in adult patients with CKD and on dialysis. FibroGen now secures

The global Phase II clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the efficacy and safety of CT-P59 in combination with standard of

In a communication received on November 24, 2020, the FDA reiterated that an inspection of the company’s manufacturing facility is required as part of the BLA approval process.

As per terms of the proposed deal, the EC can increase their purchase of Covid-19 vaccine from 80 million doses to a total of up to 160 million

Xofluza, a first-in-class and single-dose medicine, has showed efficacy in a range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in

Health Canada has provided a ‘No Objection Letter (NOL)’ for Appili’s proposed study; the U.S. FDA accepted a submission of a protocol amendment to conduct the trial in