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BioCryst Announces Acceptance of Regulatory Applications for ORLADEYO (berotralstat) by Health Canada and Swissmedic firstwordpharma
August 26, 2021
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the new drug submission for ORLADEYO®(berotralstat) has been accepted for review by Health Canada for the prevention of recurrent attacks in patients with hereditary angioedema (HAE).
CureVac Swiss AG initiates rolling submission process for mRNA-based COVID-19 vaccine candidate, CVnCoV, with Swissmedic worldpharmanews
April 26, 2021
The CureVac Swiss AG, the Swiss subsidiary of CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), announced initiation of a rolling submission for CVnCoV ...
Janssen seeks EUA for Covid-19 vaccine candidate from US FDA pharmaceutical-technology
February 07, 2021
Johnson & Johnson (J&J) unit Janssen Biotech has submitted an application seeking emergency use authorisation (EUA) for its investigational single-dose Covid-19 vaccine candidate to the US Food and Drug Administration (FDA).
Swissmedic Begins Rolling Review of Moderna’s mRNA COVID-19 Vax contractpharma
November 16, 2020
Moderna completed enrollment of its Phase 3 COVE study of mRNA-1273 on October 22.
Swissmedic accepts review of Takeda and TiGenix’s file on Cx601 pharmaceutical-technology
June 28, 2017
The Swiss Agency for Therapeutic Products (Swissmedic) has accepted a review of Takeda and TiGenix’s file on investigational compound Cx601 for the treatment of complex perianal fistulas in patients with Crohn's disease.