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The EC has granted centralized marketing authorization to Zandoriah, a biosimilar version of Forsteo (teriparatide) for the treatment of osteoporosis in adults, across all 30 EEA states
Zandoriah has demonstrated biosimilarity in line with EMA guidelines, with comprehensive comparability studies confirming similar quality, safety, and efficacy to the reference product
Teriparatide is a synthetic…
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The US FDA has granted clearance to SurGenTec's ION-L Lumbar Facet Fixation System for the treatment of skeletally mature pts with degenerative disc disease (DDD) from L3 to S1 who have failed conservative care
Clearance is supported by a multicenter, IRB-approved clinical study in a high-risk, real-world patient population, with independent radiographic reviews confirming…
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The Takeda's P-III (FirstLight & RadiantLight) trial assessed oveporexton (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO), while RadiantLight randomized 105 pts to two arms (2mg & PBO); regulatory filing is under review in the US (priority review), China & Japan
At Wk. 12,…
The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention
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The US FDA has accepted sNDA of Yeztugo (300mg, QW, PO) as a pre-exposure prophylaxis therapy for the prevention of HIV (PDUFA: Feb 02, 2027)
sNDA was supported by the P-III (PURPOSE 1 & PURPOSE 2) trials of Yeztugo, which demonstrated high efficacy across diverse global populations, incl. cisgender women, cisgender men & gender-diverse…
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The USDA has approved Elanco's TruCan Ultra Lyme-L4 to protect dogs against both Lyme disease and leptospirosis, expanding its extensive TruCan Ultra Portfolio
TruCan Ultra Lyme-L4 uses Elanco’s PureFil Tech to reduce vaccination reactions & is available in a 1/2mL formulation that delivers the same broad protection as the 1 mL version, enabling comprehensive…
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Akeso has enrolled the first patient in the P-Ib/II (AK138D1-202) study assessing its AK138D1 monotx. or in combination with ivonescimab for the treatment of advanced breast cancer
The trial is evaluating AK138D1 in 2 breast cancer subtypes: HR+/HER2- & triple-negative breast cancer. The study incl. pts ranging from treatment-naïve to heavily pretreated & enrolls…
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Eli Lilly reported the P-I (AJX-101) trial, assessing AJ1-11095 (25, 50, 75, 100, & 125mg, QD) in 23 pts with myelofibrosis who have been failed by a type I JAK2 inhibitor, at EHA 2026
AJ1-11095 achieved a 70% SVR35 & 70% TSS50 rate at Wk. 12, with driver mutation VAF reductions observed in 21 pts;…
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The US FDA has accepted sBLA & granted priority review to AZ's Ultomiris (ravulizumab) for the treatment of adults with immunoglobulin A nephropathy (IgAN), with a PDUFA action date anticipated in Q4’26
sBLA was supported by the interim analysis data from the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with…
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The ANVISA has approved Uztok, a biosimilar version of Stelara (ustekinumab)
Ustekinumab is a human interleukin-12 and -23 antagonist
Uztok is indicated for Plaque psoriasis, Psoriatic arthritis, Crohn's disease, and Ulcerative colitis
Ref: Gov.br | Image: SteinCares | Press Release
Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with…
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The ANVISA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept)
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor
Eydenzelt is indicated for adults with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (CRVO/BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (CNV)
Ref: Gov.br | Image: Celltrion | Press Release
Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea …

