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Activate Immunotherapy

Latest From Activate Immunotherapy

Cancer, Gene Therapy Top US FDA’s Second Half 2024 User Fee Calendar

Novel agents in immuno-oncology headline the drug center’s upcoming goal dates, while gene therapies make up most of the biologic center’s workload.

US FDA Performance Tracker Approvals

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

Ensho Joins Race To Develop An Oral Integrin Inhibitor For IBD

Ensho Therapeutics is raising series A cash to develop Phase II-ready NSHO-101 (EA1080), a third oral ɑ4β7 integrin inhibitor attempting to take on Takeda’s blockbuster injectable Entyvio.

Deals StartUps and SMEs
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