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Schering-Plough Corporation

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Latest From Schering-Plough Corporation

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

Scholar Rock And Biohaven Get Ready To Flex Their Muscles In SMA

The companies are set to present Phase III results from their rival myostatin inhibitor drugs for spinal muscular atrophy in Q4, while also fast-tracking the candidates in obesity studies.

Commercial Companies

US R&D Setbacks For Multiple Japanese Firms

Several Japanese firms are facing R&D challenges and setbacks in the US, in the form of missed Phase III endpoints, trial recruitment difficulties and a Complete Response Letter.

Research & Development Clinical Trials

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
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Company Information

  • Other Names / Subsidiaries
    • Integrated Therapeutics Group
    • Nobilon International BV
    • Organon BioSciences
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