Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Shots: The EC has approved Sanofi's Teizeild (Tzield outside the EU) to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the other regions Approval was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32)…

ByRidhi Rastogi4 days ago

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Annexon Seeks European Approval of Tanruprubart for Guillain-Barré Syndrome

Shots: The EMA has received MAA of tanruprubart for the treatment of Guillain-Barré syndrome (GBS) The MAA dossier demonstrated rapid neuroinflammation control & improved recovery, supported by a PoC study & a P-III trial against PBO, favorable risk/benefit, robust US & Southeast Asian biomarker data, PK (US/EU/SE Asia), & RWE matching P-III outcomes to IVIg…

ByRidhi RastogiJanuary 9, 2026

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Omeros Receives the FDA Approval for Yartemlea (Narsoplimab-wuug) to Treat TA-TMA

Shots: The US FDA has approved Yartemlea for the treatment of HSCT-Associated Thrombotic Microangiopathy, with US launch planned for Jan 2026. MAA is under the EMA’s review, with a decision expected in mid-2026 Approval was based on the TA-TMA Study (n=28) plus EAP (N=221 adults & pediatric pts), where 19 pts (13 adult & 6…

ByRidhi RastogiDecember 26, 2025

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New Drug Designations – November 2025

Shots: PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA  The November 2025 report covers designations granted to 22 drugs and 1 medical device, spanning 8 small molecules, 8 biologics, 2 cell and gene therapies & 1 medical…

ByRidhi RastogiDecember 23, 2025

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Daiichi Sankyo Reports the EMA’s MAA Validation of Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The EMA has validated the Type II Variation MAA for Daiichi's Datroway (datopotamab deruxtecan) as monotx. For the 1L treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy; additional regulatory filings are underway MAA was supported by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644…

ByRidhi RastogiDecember 19, 2025

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Lupin Receive the CHMP Positive Opinion for Ranluspec (Biosimilar, Lucentis)

Shots: The CHMP has recommended marketing authorization for Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab) Opinion was supported by analytical similarity data and a global P-III trial (n=600 pts) in neovascular AMD across the US, EU, Russia, and India Under the agreement, Lupin’s biosimilar ranibizumab will be marketed by Sandoz across the EU (excluding Germany),…

ByDipanshu DixitDecember 17, 2025

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EMA Marketing Authorization of New Drugs in November 2025

Shots: Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier In November, the EMA issued positive CHMP opinions for six significant therapies and 2 EU approval: Sanofi’s Teizeild (Teplizumab) to delay the onset of stage 3 type 1 diabetes, and Ionis and Otsuka’s Dawnzera (Donidalorsen) for the routine prevention of HAE attacks In…

ByDipanshu DixitDecember 16, 2025

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STADA & Bio-Thera Receive the CHMP Positive Opinion for Gotenfia (Biosimilar, Simponi)

Shots: The CHMP has recommended STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), for EC approval valid in all 30 EEA states Opinion was based on extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects, plus P-III…

ByRidhi RastogiDecember 12, 2025

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Samsung Bioepis Receive the CHMP Positive Opinion for Byooviz (Biosimilar, Lucentis)

Shots: The CHMP has recommended Samsung Bioepis’ Byooviz (0.5 mg/0.05 ml PFS), a biosimilar version of Lucentis (ranibizumab). The PFS presentation is expected to launch in Q2’26 Byooviz is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and…

ByDipanshu DixitDecember 2, 2025

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AbbVie Reports P-III (ECLIPSE) Trial Data on Aquipta (Atogepant) for the Acute Treatment of Migraine

Shots: AbbVie has reported the P-III (ECLIPSE) trial data assessing Aquipta/Qulipta (atogepant, 60mg, PO, QD) vs PBO as an acute treatment of migraine in 1,223 adults (with or without aura) Trial met its 1EP, showing atogepant was superior to PBO for pain freedom at 2hrs. in the first treated migraine attack (with or without aura; 24.3%…

ByRidhi RastogiDecember 1, 2025

Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Annexon Seeks European Approval of Tanruprubart for Guillain-Barré Syndrome

Omeros Receives the FDA Approval for Yartemlea (Narsoplimab-wuug) to Treat TA-TMA

New Drug Designations – November 2025

Daiichi Sankyo Reports the EMA’s MAA Validation of Datroway to Treat Metastatic Triple Negative Breast Cancer

Lupin Receive the CHMP Positive Opinion for Ranluspec (Biosimilar, Lucentis)

EMA Marketing Authorization of New Drugs in November 2025

STADA & Bio-Thera Receive the CHMP Positive Opinion for Gotenfia (Biosimilar, Simponi)

Samsung Bioepis Receive the CHMP Positive Opinion for Byooviz (Biosimilar, Lucentis)

AbbVie Reports P-III (ECLIPSE) Trial Data on Aquipta (Atogepant) for the Acute Treatment of Migraine

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