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Mabwell’s Adalimumab Injection (Biosimilar, Humira) Granted Marketing Approval in Indonesia

Shots: Mabwell’s Adalimumab Injection 9MW0113 (marketed as JUNMAIKANG in China), a Humira biosimilar, has received marketing authorization from Indonesia’s BPOM Adalimumab Injection 9MW0113, co-developed by Mabwell and Junshi Biosciences. Mabwell has submitted registration applications in multiple countries, including Jordan and Peru, and has agreements in over ten markets Adalimumab is a TNF blocker, binds TNF‑alpha…

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Axsome

Axsome Therapeutics Reports the US FDA’s sNDA Acceptance with Priority Review of AXS-05 for the Treatment of Alzheimer’s Disease Agitation

Shots: The US FDA has accepted sNDA & granted priority review to AXS-05 (dextromethorphan HBr and bupropion HCl) to treat Alzheimer’s disease agitation (PDUFA: April 30, 2026) The sNDA reflects AXS-05’s clinical development program in Alzheimer’s disease agitation, which included four randomized, double-blind P-III trials and a long-term safety study AXS-05 is an oral investigational…

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