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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

If successful, this pharmacologic approach could substantially change the treatment paradigm for OSA patients. “There is a clear unmet need for an approach that addresses the underlying cause

City of Hope will assess the investigational vaccine, dubbed COH04S1, in healthy volunteers aged between 18 and 55 who have not had Covid-19. The investigational vaccine is being

RSV is responsible for respiratory infections such as bronchiolitis and viral pneumonia in infants. It is estimated that in the world, 33 million cases of RSV occur in

The partnership aims to advance HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment of COVID-19, through clinical development and commercial sale in Russia, pending approval from the Ministry

BASIS is a global Phase 3, open-label, multicenter study that will evaluate annualized bleed rate (ABR) through 12 months on prophylaxis treatment with marstacimab, an investigational, novel subcutaneous