Daily Top News

September 13, 2021
Daily Top News

Nuwiq(simoctocogalfa) / Octapharma
Octapharm aannounces FDA approval of updated NUWIQ Prescribing Information to include immunogenicity data in previously untreated patients (Businesswire) - Oct 19, 2020 - "Octapharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved an updated Prescribing Information (PI) for NUWIQ...for the prevention and treatment of bleeding in people with haemophilia A. The updated PI includes immunogenicity data from the NuProtect study in previously untreated patients(PUPs)." 

Taltz(ixekizumab)/ Eli Lilly, Second Xiangya Hospital of Central South University
Health Canada has approved TALTZ (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) (CanadaNewswire) - Oct 19, 2020 - "On October 14, 2020, Health Canada approved TALTZ® for the treatment of adult patients with active non-radiographic axial spondy loarthritis (nr-axSpA) with objective signs of inflammation who have responded inadequately to, or are intolerant to conventional therapy....This approval is based on the results from the Phase 3COAST-X trial..." 

Venclexta (venetoclax) / Roche, AbbVie
AbbVie’s Venclexta granted full US approval in AML (PharmaTimes)- Oct 19, 2020 - "The US Food and Drug Administration (FDA) has fully approved AbbVie’s Venclexta in acute myeloid leukemia (AML)...Venclexta(venetoclax) has been approved in combination with azacytidine ordecitabine/low-dose cytarabine (LDAC) for the treatment of newly-diagnosed AML in adults who are aged 75 years or older...The approval is based on data from the phase III VIALE-A and VIALE-C studies..."

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