Sanofi Reports the CHMP Positive Opinion for Cenrifki (Tolebrutinib) to Treat Non-Relapsing SPMS

Shots: The CHMP has recommended Sanofi's Cenrifki for the treatment of SPMS without relapses in the last 2yrs.; regulatory submissions are ongoing in other regions Opinion was backed by P-III (HERCULES) trial in non-relapsing SPMS & supporting data from P-III (GEMINI 1 & 2) studies in relapsing multiple sclerosis, with HERCULES demonstrating delayed onset of…

ByRidhi RastogiApril 27, 2026

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Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: FDA has approved Dupixent to treat CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, & P-III (CUPIDKids) trial Study A & C assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg received 200mg) vs PBO…

ByRidhi RastogiApril 23, 2026

NEWS

Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

Shots: The US FDA has approved Sanofi's Tzield (teplizumab-mzwv), under priority review, to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D Approval was supported by 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of Tzield (IV, QD for 14 consecutive days) in…

ByRidhi RastogiApril 22, 2026

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Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: The EC has approved Dupixent to treat mod. to sev. CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment & naïve to anti-IgE therapy based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, and CUPIDKids Study A & C assessed Dupixent (LD → 300mg Q2W or 200mg Q2W for…

ByDipanshu DixitApril 13, 2026

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Sanofi Reports Market Authorization for Nuvaxovid, Expanding COVID-19 Vaccine Options in Canada

Shots: Sanofi became the Nuvaxovid market authorization holder in Canada to supply the protein-based COVID-19 vaccine. Nuvaxovid to be available in Canada for the fall 2026-2027 season Authorization was supported by pivotal P-III trials demonstrating ~90% efficacy of Nuvaxovid in preventing symptomatic COVID-19. Demonstrated a favourable tolerability profile, supporting its use for seasonal vaccination Nuvaxovid…

ByDipanshu DixitApril 9, 2026

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Sanofi Reports P-II Trial Results on Lunsekimig Across Multiple Immunology & Inflammatory Indications

Shots: Sanofi has reported P-IIb (AIRCULES), P-IIa (DUET) PoC & P-IIb (VELVET) data assessing lunsekimig (SC) in adults with mod. to sev. asthma, CRSwNP, & in mod. to sev. atopic dermatitis, respectively In AIRCULES, lunsekimig met 1 & 2EPs, reducing exacerbations & improving lung fuction as measured by pre-BD FEV1 vs PBO, while in DUET it met…

ByRidhi RastogiApril 7, 2026

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Sanofi Reports the EC Approval of Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Shots: The EC has approved Rezurock (200mg) to treat chronic GVHD pts (≥12yrs., ≥40kg) Approval was based on safety and efficacy clinical data, incl. the P-II (ROCKstar) trial (n=77), which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic therapies Under the conditional marketing authorisation, Sanofi will conduct a confirmatory randomized study Ref:…

ByDipanshu DixitMarch 26, 2026

NEWS

Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

Shots: The Japanese MHLW has approved Dupixent to treat adults with mod. to sev.bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks. Pts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks. 4 to 6 if disease control was…

ByRidhi RastogiMarch 25, 2026

NEWS

Kali Therapeutics Partners with Sanofi for KT501 in a ~$1.2B Deal

Shots: Kali Therapeutics has entered into a license agreement with Sanofi for KT501 to treat a broad range of B cell-mediated autoimmune diseases As per the deal, Sanofi will obtain exclusive worldwide rights to KT501, while Kali will receive upfront & near-term payments totaling $180M and up to $1.05B in development & commercial milestones, with tiered royalties…

ByRidhi RastogiMarch 23, 2026

NEWS

Sanofi’s Venglustat Secures the US FDA Breakthrough Therapy Designation for Type 3 Gaucher Disease

Shots: The US FDA has granted BTD to venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3) Designation was based on the P-III (LEAP2MONO) study assessing venglustat (QD, PO) vs imiglucerase (Q2W) in 43 pts (≥12yrs.), which showed significant improvements in neurological symptoms measured by a global test scores, incl. mSARA & RBANS Venglustat received US…

ByRidhi RastogiMarch 18, 2026

Sanofi Reports the CHMP Positive Opinion for Cenrifki (Tolebrutinib) to Treat Non-Relapsing SPMS

Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Sanofi Reports Market Authorization for Nuvaxovid, Expanding COVID-19 Vaccine Options in Canada

Sanofi Reports P-II Trial Results on Lunsekimig Across Multiple Immunology & Inflammatory Indications

Sanofi Reports the EC Approval of Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

Kali Therapeutics Partners with Sanofi for KT501 in a ~$1.2B Deal

Sanofi’s Venglustat Secures the US FDA Breakthrough Therapy Designation for Type 3 Gaucher Disease

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