EMA Marketing Authorization of New Drugs in January 2026

Shots: The European Commission approved multiple therapies across vaccines, rare diseases, endocrinology, and immunology, including products from BioNet, Sanofi, Fondazione Telethon, IntraBio, and Ionis / Otsuka. The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from UCB and Gedeon Richter, with additional recommendations supporting Sanofi’s Rezurock. Decisions were backed by strong Phase II/III data…

ByDipanshu DixitFebruary 17, 2026

NEWS

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

NEWS

Corcept Receives US FDA Complete Response Letter for Relacorilant in Hypercortisolism

Shots: The US FDA has issued a Complete Response Letter (CRL) to Corcept for the NDA of relacorilant for the treatment of hypertension secondary to hypercortisolism While the US FDA acknowledged that the pivotal P-III (GRACE) study met its 1EP and that data from the GRADIENT study provided supportive evidence, the Agency concluded that additional…

ByDipanshu DixitJanuary 2, 2026

NEWS

Foresee Pharmaceuticals Reports P-III (Casppian) Study Data of FP-001 in Children with CPP

Shots: Foresee Pharmaceuticals reported its P-III (Casppian) Study data of FP-001 (leuprolide mesylate 42mg; administered every six months), a sustained-release GnRH agonist, met its 1EP in children with central precocious puberty (CPP) The study showed that 94% of pts achieved serum LH suppression to <4 mIU/mL at 60 mins. following a GnRHa stimulation test at Wk.…

ByPrince GiriDecember 25, 2025

VIEWPOINTS

Helen Yeh & Naim Shehadeh in a Stirring Conversation with PharmaShots, Highlight the Results from T2NOW Study

Shots: At the EASD, AZ announced positive results from the T2NOW P-III study that evaluated the efficacy and safety of Forxiga as an add-on treatment in children and adolescents with T2D receiving metformin, insulin, or both Helen Yeh, VP, CVRM Therapy Area Biopharmaceuticals Medical at AstraZeneca, and Naim Shehadeh, Professor of Endocrinology, Rambam Health Care…

BySaurabh ChaubeyDecember 11, 2023

EMA Marketing Authorization of New Drugs in January 2026

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

Corcept Receives US FDA Complete Response Letter for Relacorilant in Hypercortisolism

Foresee Pharmaceuticals Reports P-III (Casppian) Study Data of FP-001 in Children with CPP

Helen Yeh & Naim Shehadeh in a Stirring Conversation with PharmaShots, Highlight the Results from T2NOW Study

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