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 Dixit7 hours ago

NEWS

Dren Bio and Sanofi Forge ~$1.8B Deal to Advance Next-Generation B-Cell Depletion Therapy

Shots: Dren Bio has partnered with Sanofi to discover & develop next-generation B-cell depleting therapy for the treatment of various autoimmune diseases As per the deal, Dren Bio will receive $100M upfront & ~$1.7B in milestones, with both parties jointly leading discovery & preclinical work using Dren Bio’s platform, after which Sanofi will handle…

ByRidhi Rastogi10 hours ago

NEWS

ADEL and Sanofi Ink ~$1.04B Global Licensing Deal for ADEL-Y01

Shots: ADEL has entered into an exclusive worldwide license agreement with Sanofi for the development & commercialization of ADEL-Y01 & related backup compounds As per the deal, ADEL will receive a non-refundable payment of $80M upfront plus development & commercial milestones, representing the total deal value of ~$1.04B, tiered royalties on net sales ranging up…

ByRidhi Rastogi14 hours ago

NEWS

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 (≥12yrs.), 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 Study A & C (N=284) assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg…

ByRidhi RastogiNovember 25, 2025

TOP 20

Top 20 Prescription Drugs of 2025

Shots: In 2025, the global Prescription Drugs market is projected to generate an impressive $1.13T, with steady annual growth of 3.94% expected through 2030, ultimately reaching $1.37T. Leading the pack is Keytruda, securing the first position with $29.48B, closely followed by Ozempic at $28.18B, and Eliquis, which recorded $20.69B in global sales. Fourth position is…

ByPrince GiriNovember 20, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in October 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 October, the EMA issued positive CHMP opinions for two significant therapies: Sanofi’s Wayrilz (rilzabrutinib) for adults with immune thrombocytopenia, and Insmed’s Brinsupri (brensocatib) for the…

ByDipanshu DixitNovember 18, 2025

NEWS

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

Shots: The CHMP has recommended Teizeild 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 Opinion was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32) for 14 days in 76…

ByRidhi RastogiNovember 17, 2025

NEWS

Sanofi Reports P-II (ElevAATe) Trial Data on Efdoralprin Alfa for Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

Shots: Sanofi has reported the P-II (ElevAATe) trial data assessing efdoralprin alfa (Q3W or Q4W) vs SoC plasma-derived augmentation therapy (QW) in 97 adults with AATD emphysema for ~32wks. Trial met its 1EP with a greater mean increase in functional AAT (fAAT) levels at Wk. 32 & achieved key 2EPs of higher fAAT levels &…

ByRidhi RastogiOctober 24, 2025

NEWS

Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

Shots: The CHMP has recommended Wayrilz (rilzabrutinib) for adults with ITP unresponsive to other treatments, with a final decision expected soon; under regulatory review for ITP in China Opinion was based on the P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO during a 12–24-wk, followed by 28 wks, and then a four-week…

ByDipanshu DixitOctober 22, 2025

NEWS

EVOQ Therapeutics Signs a ~$500M Deal with Sanofi for NanoDisc Technology

Shots: EVOQ Therapeutics has entered into a collaboration & license agreement with Sanofi to advance EVOQ’s NanoDisc tech in immunology As per the deal, both companies will jointly lead research activities, with Sanofi responsible for global development & commercialization efforts. In exchange, EVOQ will receive over $500M, incl. upfront, preclinical, development & sales milestones, with tiered…

ByRidhi RastogiOctober 17, 2025

EMA Marketing Authorization of New Drugs in November 2025

Dren Bio and Sanofi Forge ~$1.8B Deal to Advance Next-Generation B-Cell Depletion Therapy

ADEL and Sanofi Ink ~$1.04B Global Licensing Deal for ADEL-Y01

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

Top 20 Prescription Drugs of 2025

EMA Marketing Authorization of New Drugs in October 2025

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

Sanofi Reports P-II (ElevAATe) Trial Data on Efdoralprin Alfa for Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

EVOQ Therapeutics Signs a ~$500M Deal with Sanofi for NanoDisc Technology

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