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BioWorld - Friday, April 10, 2026
Home » Topics » Regulatory

Regulatory
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Regulatory front for Feb. 4, 2020

Feb. 4, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Sanofi, Glaxosmithkline, Novartis.
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Architectural pillars

Regulatory front for Feb. 4, 2020

Feb. 4, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: U.S. Department of Justice
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FDA approves Audenz to protect against influenza A (H5N1)

Feb. 4, 2020

Regulatory front for Feb. 3, 2020

Feb. 3, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Johnson & Johnson.
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Influenza A protection and a peanut allergy treatment receive FDA approvals

Feb. 3, 2020
By Lee Landenberger
The FDA has issued two new approvals, one for a cell-based pandemic influenza A (H5N1) vaccine and the other is the first approval for treating peanut allergy.
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Australia’s Mesoblast submits final module of rolling BLA submission for pediatric GVHD stem cell therapy

Feb. 3, 2020
By Tamra Sami
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. has filed the final module of its rolling BLA submission for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, after it showed strong survival rates in children with acute steroid-refractory graft-vs.-host disease (aGVHD).
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Japan’s drug repricing plan to hit some top sellers

Feb. 3, 2020
By Jihyun Kim
HONG KONG – Aiming to increase the financial stability of the national health care insurance system, Japan has announced a list of 17 drugs for which prices will be reduced.
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Regulatory front for Feb. 3, 2020

Feb. 3, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Vanda Pharmaceuticals.
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FDA approves Palforzia oral immunotherapy for peanut allergy

Feb. 3, 2020
Brexit hourglass illustration

Brexit day arrives; industry continues to face lack of clarity as transition period begins

Jan. 31, 2020
By Nuala Moran
LONDON – Brexit finally becomes a reality at midnight central European time on Jan. 31, but for the life sciences industry uncertainty continues, as the U.K. enters an 11-month transition phase during which the terms of its future relationship with the EU must be negotiated.
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