Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog)

Shots: The US FDA has approved Garzulys (SC & IV), a biosimilar to NovoLog (insulin aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus Garzulys was developed through a collaboration among Tonghua Dongbao, NKF, Xentria, Meitheal, & Emerge. Tonghua Dongbao developed the drug substance, NKF the drug product, Xentria led clinical…

ByRidhi RastogiAugust 3, 2026

Sandoz Receives EC Approval of Ondibta (Biosimilar, Lantus and SoloStar)

Shots: The EC has approved Ondibta, a biosimilar insulin glargine pre-filled pen, reference medicine Lantus and SoloStar, developed and registered by Gan & Lee Pharmaceuticals, anticipated launch by early 2027 Ondibta is approved for treating diabetes mellitus in pts (age≥ 2 yrs.) and matches Lantus, SoloStar in safety, quality, and efficacy In Dec 2018, Sandoz partnered with…

ByDipanshu DixitJanuary 15, 2026

Ascletis Pharma Receives the US FDA IND Clearance to Initiate P-II Trial of ASC30 for Type 2 Diabetes

Shots: FDA has granted IND clearance to initiate its P-II trial of ASC30 (40, 60 & 80mg) vs PBO in ~100 pts with type 2 diabetes mellitus, with enrolment expected to begin in Q1’26 Trial will assess mean change in HbA1c up to 13wks. as 1EP & 2EPs will incl. mean change in fasting blood…

ByRidhi RastogiJanuary 5, 2026

Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog)

Sandoz Receives EC Approval of Ondibta (Biosimilar, Lantus and SoloStar)

Ascletis Pharma Receives the US FDA IND Clearance to Initiate P-II Trial of ASC30 for Type 2 Diabetes

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