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The FDA has set a Prescription Drug User Fee Act (“PDUFA”) target date of May 21, 2021. “The FDA’s acceptance of our BLA and granting of priority review

The companies have submitted a request to the FDA to secure FDA EUA status for BNT162b2 mRNA vaccine candidate against SARS-CoV-2. The Covid-19 vaccine is expected to be

“We are encouraged by the European Commission’s and European Medicines Agency’s recognition of the benefit that zanidatamab can provide in the treatment of HER2-expressing gastric cancers as we

ARDS is an area of significant unmet need, with an approximate 40% mortality rate with current standard of care, which includes prolonged ICU treatment and mechanical ventilation.1,2 As

The EUA status facilitates distribution and emergency use of baricitinib in combination with remdesivir in hospitalised adult and paediatric patients two years of age or older with suspected

“The FDA’s decision supports our ability to provide a new treatment option for critically ill COVID-19 patients with bacterial infections resistant to nearly all other available therapies. This

In addition, following positive Phase 1/2 study results, a Phase 3 study evaluating rilzabrutinib for ITP has been initiated. Rilzabrutinib received orphan drug designation from the FDA for

The data analysis showed a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (primary infection), as well as in participants with and without prior SARS-CoV-2

The trial is enrolling adult epilepsy patients with temporal lobe onset, with or without secondary generalized seizures. A clinical feasibility study at St. Vincent’s Hospital Melbourne (published in The