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Rocket Pharmaceuticals Inc.

http://www.rocketpharma.com/

Latest From Rocket Pharmaceuticals Inc.

Quality Issues Star In US FDA Complete Response Letter Trio

Rocket Pharmaceuticals’ gene therapy Kresladi, Daiichi Sankyo/Merck’s patritumab deruxtecan, and AbbVie’s foscarbidopa/foslevodopa (ABBV-951) received CRLs because of manufacturing concerns.

Complete Response Letters Manufacturing

US FDA’s Dry July? Few Goal Dates Portend Quiet Month For Approvals

Sun’s deuruxolitinib and Novo Nordisk’s insulin icodec stand out as new molecular entities among the small cluster of US FDA user fee goal dates in July.

US FDA Performance Tracker Review Pathway

US FDA’s June Approvals Forecast: Nearly 30 Goal Dates Suggest Hot Start To Summer

June goal dates include RSV and pneumococcal vaccines, two COPD therapies, Rocket and Sarepta gene therapies, and lots of oncology.

US FDA Performance Tracker Drug Review

Marching On: Eight Novel Agents Among March Goal Dates For US FDA

Crowded calendar could bring to an end the slow start for novel approvals in 2024, as decisions come due for Lilly’s donanemab, Merck’s sotatercept, Regeneron’s odronextamab and more.

US FDA Performance Tracker Approvals
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Biotechnology
    • Gene Therapy, Cell Therapy
  • Other Names / Subsidiaries
    • Inotek Pharmaceuticals
    • Renovacor Inc.
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