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BioWorld - Saturday, June 13, 2026
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Home » Topics » BioWorld, Regulatory

BioWorld, Regulatory
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Lilly wins approval for first Loxo-sourced asset, Retevmo

May 11, 2020
By Michael Fitzhugh
About 15 months after closing its multibillion-dollar acquisition of Loxo Oncology Inc., Eli Lilly and Co. has secured an accelerated FDA approval for the first of the deal's headline assets, the RET kinase inhibitor selpercatinib, now branded as Retevmo.
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Regulatory front for May 11, 2020

May 11, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Gilead, Eagle, Slayback, Apotex.
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Regulatory actions for May 11, 2020

May 11, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, Appili, Astrazeneca, Bellerophon, Crispr, Daiichi, Histogen, Lilly, Merck, Relief, Tracon, Vertex.
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Bridge Biotherapeutics receives MFDS approval for EGFR drug in lung cancer

May 8, 2020
By Gina Lee
HONG KONG – South Korea’s Bridge Biotherapeutics Inc. wrapped up the week by announcing its awaited IND clearance for its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, BBT-176, for non-small-cell lung cancer (NSCLC) from the country’s Ministry of Food and Drug Safety (MFDS) on May 7.
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Approved stamp

Canbridge wins China approval for breast cancer drug Nerlynx, nod for MPS drug could come next

May 8, 2020
By Elise Mak
BEIJING – Beijing-headquartered Canbridge Pharmaceuticals Inc. is to add another source of income after Chinese regulators approved Nerlynx (neratinib) to be marketed for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.
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Japanese shield and coronavirus

Japan advances fight against COVID-19 with four-day approval for remdesivir

May 8, 2020
By Gina Lee and Alfred Romann
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
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Regulatory actions for May 8, 2020

May 8, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Arch, Bridge, Cynata, Cytokinetics, Junshi, Pluristem, Redhill, Sesen, Takeda.
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Gilead’s remdesivir receives exceptional approval in Japan for COVID-19

May 7, 2020
By Peter Winter
Just days after Foster City, Calif.-based Gilead Sciences Inc. gained emergency use authorization (EUA) from the FDA for antiviral Veklury (remdesivir) for the treatment of patients with SARS-CoV-2 infection, the virus that causes COVID-19, Japan invoked its own exceptional approval pathway to give the drug the green light to treat patients with severe COVID-19.
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Regulatory front for May 7, 2020

May 7, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Roche Holding.
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Regulatory actions for May 7, 2020

May 7, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Bexion, Canbridge, Daiichi, Genelux, Gilead, Immunicum, Nanobiotix, Novartis, Sapience, Twi.
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