Everest Medicines announces regulatory update for Nefecon in Taiwan and South Korea

By NS Healthcare Staff Writer

28 Nov 22

The Taiwan Food and Drug Administration has granted accelerated approval designation (AAD), and South Korea’s Ministry of Food…

PharmaceuticalsRegulation

AbbVie secures EC approval for Skyrizi to treat active Crohn’s disease

By NS Healthcare Staff Writer

24 Nov 22

Skyrizi is a humanised monoclonal antibody inhibitor that selectively targets interleukin-23 (IL-23), a cytokine involved in inflammatory processes,…

PharmaceuticalsRegulation

CSL Behring obtains FDA approval for Hemgenix to treat haemophilia B

By NS Healthcare Staff Writer

23 Nov 22

Hemgenix is a gene therapy that promotes continuous production of factor IX to reduce abnormal bleeding in people…

PharmaceuticalsRegulation

Jazz’ Rylaze granted expanded FDA approval for new dosing option

By NS Healthcare Staff Writer

21 Nov 22

The expanded approval adds new dosing options for Rylaze, which provides sustained asparaginase activity for adult and paediatric…

PharmaceuticalsRegulation

Provention Bio secures FDA approval for TZIELD to delay diabetes

By NS Healthcare Staff Writer

18 Nov 22

TZIELD is an anti-CD3-directed antibody, indicated for administration as a once-daily intravenous infusion for 14 days, to delay…

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US FDA approves Imfinzi, Imjudo plus chemotherapy to treat Stage IV NSCLC

By NS Healthcare Staff Writer

14 Nov 22

The FDA approval is supported by positive results from the Phase 3 POSEIDON study, which showed a significant…

PharmaceuticalsRegulation

EC approves Sanofi, GSK’s VidPrevtyn Beta Covid-19 booster vaccine

By NS Healthcare Staff Writer

11 Nov 22

VidPrevtyn Beta is a monovalent, recombinant-protein, next-generation Covid-19 vaccine developed by Sanofi, leveraging GSK’s pandemic adjuvant, and is…

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UK approves Novavax, Pfizer-BioNTech Covid-19 booster doses

By NS Healthcare Staff Writer

10 Nov 22

The British health regulator has expanded the conditional marketing authorisation (CMA) for Novavax’s Nuvaxovid as a booster dose…

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Pfizer secures FDA breakthrough therapy designation for Elranatamab

By NS Healthcare Staff Writer

04 Nov 22

The Breakthrough Therapy Designation was granted based on updated data from the Phase 2 MagnetisMM-3 study, in which…

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Gilead secures FDA nod for Vemlidy to treat chronic HBV infection in children

By NS Healthcare Staff Writer

03 Nov 22

The current FDA approval expands Vemlidy’s previous indication as a once-daily therapy to treat chronic HBV infection in…

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