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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…
January 1, 2026
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…
January 1, 2026
Elanco
Elanco Animal Health Reports the USDA Approval of Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis
Shots: The USDA has granted Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis, expected to launch in H1’26 Befrena (mAb) is an anti-IL31 injection for dogs, treats allergic and atopic dermatitis every 6–8 wks. In September, the FDA approved changes to Zenrelia (ilunocitinib tablets) US label, eliminating the fatal vaccine-induced disease risk, Elanco announced Ref:…
January 1, 2026
KORU Medical Systems Seeks FDA Clearance for FreedomEDGE System to Deliver Phesgo in HER2+ Breast Cancer Patients
Shots: The US FDA has received the 510(k) premarket notification for FreedomEDGE infusion system to subcutaneously administer Phesgo (Perjeta/Herceptin/hyaluronidase-zzxf) in HER2+ breast cancer The Infusion System enables efficient large-volume SC drug delivery, addressing unmet needs in oncology infusion centers by improving nurse administration experience while supporting faster, more streamlined clinical workflows The system supports SC…
December 31, 2025
SOFIE Biosciences Reports First Patient Dosing in P-III (FAPI-GO) Trial of [18F]FAPI-74 for Diagnosis of GI Cancer
Shots: SOFIE Biosciences has dosed the first patient with [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical, in the P-III (FAPI-GO) trial for the diagnosis of GI cancers The trial will assess the clinical utility of [¹⁸F]FAPI-74 PET/CT over 24mos. in the detection of metastatic disease in 200 adults with gastroesophageal cancer across 18 sites Another P-III (FAPI-PRO)…
December 31, 2025
Mabwell Doses First Patient in P-II Trial of 9MW3811 for Pathological Scarring
Shots: Mabwell has dosed the first patient with 9MW3811 in its P-II (CTR20254857) trial in China for pathological scarring The trial will assess safety, tolerability, PK, & preliminary efficacy of 9MW3811 in pts with pathological scarring following P-I completion in healthy subjects across Australia & China 9MW3811 has shown significant preclinical efficacy in pulmonary fibrosis…
December 31, 2025
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