Sentynl Therapeutics Reports US FDA Approval of Zycubo to Treat Pediatric Menkes Disease

Shots: The US FDA has approved Zycubo (copper histidinate) for the treatment of pediatric patients with Menkes disease Approval was supported by clinical data showing improved OS with early Zycubo treatment vs an untreated external control, reflecting ~80% reduction in the risk of death & a mOS of 177.1 vs 17.6mos. Zycubo is a bioavailable…

ByRidhi RastogiJanuary 14, 2026

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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 RastogiJanuary 12, 2026

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Arrowhead Pharmaceuticals Receives the NMPA Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: The Chinese NMPA has approved Redemplo to reduce triglycerides (TGs) in adults with FCS; regulatory review is ongoing in other regions Redemplo will be commercialized by Sanofi in Greater China under an agreement with Arrowhead, with NMPA approval triggering a $10M milestone payment from Sanofi to Arrowhead’s subsidiary Visirna Therapeutics Redemplo is an siRNA…

ByRidhi RastogiJanuary 8, 2026

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GSK Reports the MHLW Approval of Exdensur (Depemokimab) for Severe Asthma and CRSwNP

Shots: GSK’s Exdensur was approved for sev. or refractory bronchial asthma unresponsive to existing therapies & for CRSwNP in pts whose disease remains inadequately controlled with SoC, based on the P-III (SWIFT & ANCHOR) trials, respectively; filings under regulatory review in the EU & China SWIFT-1 (n=382) & SWIFT-2 (n=380) trials showed depemokimab reduced asthma…

ByRidhi RastogiJanuary 6, 2026

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Arrowhead Pharmaceuticals Receives the Health Canada Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: Health Canada has approved Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS who had an inadequate response to standard triglyceride lowering therapies Approval was based on the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts…

ByRidhi RastogiJanuary 6, 2026

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GSK Reports the NMPA Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The Chinese NMPA has approved Nucala as an add-on maintenance treatment of adults with inadequately controlled COPD characterised by eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA filing is under review MATINEE assessed Nucala (100mg, SC, Q4W) vs PBO in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…

ByRidhi RastogiJanuary 5, 2026

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Vanda Pharmaceuticals Reports the US FDA Approval of Nereus (Tradipitant) to Prevent Vomiting Induced by Motion

Shots: The US FDA has granted Nereus for the prevention of vomiting induced by motion, backed by 3 trials, incl. 2 P-III real-world boat studies (Motion Syros & Motion Serifos) & 1 supporting study in pts with documented motion sickness In Motion Syros (n=365) & Motion Serifos (n=316), vomiting incidence was 18.3–19.5% & 10.4–18.3% vs 44.3%…

ByRidhi RastogiDecember 31, 2025

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ARS Pharmaceuticals Reports NMPA Approval of neffy 2mg (Epinephrine Nasal Spray) to Treat Type I Allergic Reactions

Shots: The Chinese NMPA has approved neffy 2mg for the emergency treatment of type I allergic reactions (anaphylaxis) in adults & children (≥30kg), with availability anticipated in the spring of 2026. Filing for neffy 1mg for children (15 to <30kg) to the NMPA is expected in the coming mos. In 2021, ARS Pharma licensed neffy…

ByRidhi RastogiDecember 30, 2025

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Sanofi and Regeneron’s Dupixent (Dupilumab) Receives MHLW Approval for Children with Bronchial Asthma

Shots: The MHLW has approved Sanofi and Regeneron’s Dupixent for the treatment of bronchial asthma in children (6-11yrs.) with severe or refractory disease whose symptoms are inadequately controlled with existing therapy Approval was based on the P-III (VOYAGE) trial data in the overall population & those with a type 2 inflammation phenotype, which showed reduced…

ByRidhi RastogiDecember 26, 2025

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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

Sentynl Therapeutics Reports US FDA Approval of Zycubo to Treat Pediatric Menkes Disease

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

Arrowhead Pharmaceuticals Receives the NMPA Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

GSK Reports the MHLW Approval of Exdensur (Depemokimab) for Severe Asthma and CRSwNP

Arrowhead Pharmaceuticals Receives the Health Canada Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

GSK Reports the NMPA Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Vanda Pharmaceuticals Reports the US FDA Approval of Nereus (Tradipitant) to Prevent Vomiting Induced by Motion

ARS Pharmaceuticals Reports NMPA Approval of neffy 2mg (Epinephrine Nasal Spray) to Treat Type I Allergic Reactions

Sanofi and Regeneron’s Dupixent (Dupilumab) Receives MHLW Approval for Children with Bronchial Asthma

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

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