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

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

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Top 20 Monoclonal Antibodies of 2025

Shots: Redefining treatment paradigms, monoclonal antibody therapies utilize advanced mechanisms of action to provide care across multiple therapeutic areas As of 2024, the global monoclonal antibody therapy market was valued at $252.6B and is projected to reach $497.5B by 2029, growing at a CAGR of 14.5%. Keytruda leads the market with $29.48B in revenue, followed…

ByPrince GiriSeptember 18, 2025

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Top 20 Immunology Companies of 2025

Shots: Immunology continues to be a key focus area, with biopharmaceutical companies rigorously advancing innovative therapies including drugs, vaccines, and antibodies to address evolving patient needs and improve disease outcomes In 2024, the global immunology market size was valued at $109.4B and expected to reach $254.23B by 2032, with a CAGR of 11.8% from 2024…

ByPrince GiriJuly 24, 2025

NEWS

Regeneron and Sanofi Receive the US FDA’s Approval for Dupixent to Treat Bullous Pemphigoid

Shots: The US FDA has approved Dupixent to treat adults with bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks.; regulatory review is ongoing in the EU, Japan, & China 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.…

ByRidhi RastogiJune 20, 2025

NEWS

Regeneron Highlights Dupixent (dupilumab) Data From P-IV (DISCOVER) Study at RAD’25

Shots : Regeneron highlighted the data at RAD’25 from the P-IV (DISCOVER) study evaluating Dupixent in pts (N=120) with atopic dermatitis with skin of color that received Dupixent as monotx. Q2W based on weight after loading dose: 200mg for 30-60kg pts & 300mg for ≥60kg pts Dupixent achieved a ≥75% improvement in overall disease severity…

ByPrince GiriJune 10, 2025

TOP 20

Top 20 Biopharma Companies of 2025

Shots: Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…

ByPrince GiriApril 24, 2025

NEWS

Regeneron and Sanofi Report the US FDA’s Approval of Dupixent for Chronic Spontaneous Urticaria

Shots: The US FDA has approved Dupixent to treat CSU pts (≥12yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program; regulatory review ongoing in EU & other regions Study A & C assessed Dupixent (loading dose then 300mg Q2W; pts weighing <60kg received 200mg)…

ByRidhi RastogiApril 21, 2025

NEWS

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots: Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapy Approval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…

ByRidhi RastogiMarch 28, 2025

NEWS

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

Shots: The US FDA has accepted & granted priority review to the sBLA of Dupixent for the treatment of adults with BP (PDUFA: Jun 20, 2025) sBLA was supported by P-II/III (ADEPT) trial assessing Dupixent vs PBO in pts (n=106) for 52wks., that met its 1EP of 5x pts achieving sustained disease remission at…

ByRidhi RastogiFebruary 18, 2025

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

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

Top 20 Monoclonal Antibodies of 2025

Top 20 Immunology Companies of 2025

Regeneron and Sanofi Receive the US FDA’s Approval for Dupixent to Treat Bullous Pemphigoid

Regeneron Highlights Dupixent (dupilumab) Data From P-IV (DISCOVER) Study at RAD’25

Top 20 Biopharma Companies of 2025

Regeneron and Sanofi Report the US FDA’s Approval of Dupixent for Chronic Spontaneous Urticaria

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

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