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NEWS

CinnaGen Reports the EC Approval of Zandoriah (Biosimilar, Forsteo)

Shots: 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…
June 16, 2026

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NEWS

SurGenTec Wins the US FDA Clearance for ION-L to Treat Degenerative Disc Disease

Shots: 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…
June 16, 2026

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Elanco
NEWS

Elanco Receives the USDA Approval for TruCan Ultra Lyme-L4 Combination Vaccine to Protect Dogs Against Lyme and Leptospirosis

Shots: 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…
June 16, 2026

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Akesobio
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Akeso Reports First Patient Enrolment in P-Ib/II Trial of AK138D1 ± Ivonescimab for Breast Cancer

Shots: 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…
June 15, 2026

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Astrazeneca
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AstraZeneca Reports FDA’s sBLA Acceptance Under Priority Review for Ultomiristo Treat IgA Nephropathy

Shots: 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…
June 15, 2026

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Sanofi
NEWS

Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

Shots: The US FDA has granted accelerated approval to Sanofi's Tzield to delay the decline in endogenous (own) insulin production in pts (8-17yrs.) recently diagnosed with stage 3 T1D Approval was based on the P-III (PROTECT) trial assessing Tzield (n=217) vs PBO (n=111) in 328 children & adolescents (8-17yrs.) diagnosed with clinical stage 3 T1D…
June 15, 2026

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Merck new
NEWS

Merck Reports FDA Approval of Keytruda/Keytruda QLEX + Welireg in Clear Cell Renal Cell Carcinoma

Shots: The US FDA has approved MSD's Welireg + Keytruda/Keytruda QLEX as adj. therapy in clear cell renal cell carcinoma (ccRCC) pts at intermediate-high or high risk of recurrencepost-nephrectomy or post-nephrectomy & resection of metastatic lesions Approval was backed by the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO)…
June 15, 2026

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