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Browsing Tag

FDA approval

12 posts
GGSK
GSK partner Hansoh reports another phase 3 win for priority ADC
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Nuvalent deal delivers GSK’s first-ever lung cancer approval

  • August 13, 2026
In a landmark moment for its oncology ambitions, GSK has secured FDA approval for Jideytro (zidesamtinib) as the…
GGSK
GSK wins FDA approval for oral cUTI antibiotic | GSK SEC Filing
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GSK FDA Approves Jideytro; 44% Response Rate

  • July 23, 2026
Approval based on ARROS-1 phase I/II trial demonstrating meaningful and durable responses in patients with locally advanced or…
GGSK
GSK wins FDA approval for oral cUTI antibiotic | GSK SEC Filing
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GSK wins FDA nod for Jideytro lung cancer drug | GSK SEC Filing

  • July 23, 2026
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549   Form 6-K   REPORT OF FOREIGN PRIVATE ISSUER…
GGSK
Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer
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Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer

  • July 23, 2026
Approval based on ARROS-1 phase I/II trial demonstrating meaningful and durable responses in patients with locally advanced or…
AAstraZeneca
Lung Cancer
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AstraZeneca Pays $600M for Oral Pill That Beat Chemo in Rare Lung Cancer

  • July 15, 2026
For years, patients with a specific genomic subtype of lung cancer faced a stark choice: intravenous chemotherapy, or…
GGSK
photograph taken February 2 2022 shows logo
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Surgery-Free Rectal Cancer Treatment Edges Closer as Dostarlimab Clears Registrational Trial

  • July 14, 2026
GSK announced Sunday that dostarlimab (Jemperli), its PD-1–blocking immunotherapy, met the primary endpoint of the AZUR-1 registrational Phase…
GGSK
GSK (LSE:GSK) Wins FDA Approval For Utebzi As Momelotinib Gains Orphan Tag
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GSK (LSE:GSK) Wins FDA Approval For Utebzi As Momelotinib Gains Orphan Tag

  • June 26, 2026
Find winning stocks in any market cycle. Join 7 million investors using Simply Wall St’s investing ideas for…
GGSK
GSK wins FDA approval for oral cUTI antibiotic | GSK SEC Filing
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GSK wins FDA approval for oral cUTI antibiotic | GSK SEC Filing

  • June 20, 2026
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549   Form 6-K   REPORT OF FOREIGN PRIVATE ISSUER…
AAstraZeneca
AstraZeneca’s New FDA Wins Raise Questions On Growth And Valuation
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AstraZeneca (LSE:AZN) Stock Fair Value Edges Lower After Pipeline And Pricing Debate

  • June 20, 2026
Get insights on thousands of stocks from the global community of over 7 million individual investors at Simply…
AAstraZeneca
AstraZeneca’s New FDA Wins Raise Questions On Growth And Valuation
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AstraZeneca (LSE:AZN) Stock Fair Value Edges Lower After Pipeline And Pricing Debate

  • June 20, 2026
Get insights on thousands of stocks from the global community of over 7 million individual investors at Simply…
GGSK
FDA approves GSK, Spero's oral treatment for complicated UTIs
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FDA approves GSK, Spero’s oral treatment for complicated UTIs

  • June 18, 2026
GSK and Spero Therapeutics have scored an FDA approval for Utebzi as the first oral carbapenem antibiotic for…
AAstraZeneca
AstraZeneca’s New FDA Wins Raise Questions On Growth And Valuation
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AstraZeneca’s New FDA Wins Raise Questions On Growth And Valuation

  • May 20, 2026
Find your next quality investment with Simply Wall St’s easy and powerful screener, trusted by over 7 million…
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