Junshi Biosciences/Immorna Joint Venture
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Latest From Junshi Biosciences/Immorna Joint Venture
Keeping Track: US FDA Drugs Center Passes 50 Novel Agent Approvals In 2023
AstraZeneca’s Truqap and Evive’s Ryzneuta bring FDA center for drugs’ 2023 novel agent total to 51, while biologics center already sits on a record-breaking 14 novel approvals.
Rozanolixizumab & Biosimilar Ustekinumab Among Raft Of New Drugs Filed In EU
The European Medicines Agency’s latest list of drugs under review for potential marketing approval includes a second generalized myasthenia gravis treatment from UCB and what could become the first biosimilar version of Stelara in the EU.
With 37 Novel Approvals in 2022, US FDA CDER’s Five-Year Hot Streak Comes To An End; Gene Therapies Carry CBER To 8 Novel Approvals
US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.
Sanofi, Innovent Link On China Oncology Ambitions As ADCs Surge
The antibody-drug conjugate market is emerging as the next battleground for intense competition in China, with global partnerships becoming essential to win, as evidenced by a major new alliance between Innovent and Sanofi.
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