Pharmafile Logo

News and Press Releases

Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria

Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria Approval based on phase 3 studies showing Dupixent significantly...

Category: Drug Discovery, Other, Pharmaceutical
Posted: November 25, 2025

Regeneron
ukinfo@regeneron.com
The Charter Building, Vine Street, Uxbridge, Middlesex, United Kingdom, UB8 1JG

Commit Biologics achieves proof-of-concept for novel Complement Engager platform in non-human primates

Novel approach harnessing the power of the complement system to drive potent cell depletion Single-dose study shows rapid and sustained immune cell depletion in blood and tissues with a very...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 11, 2025

Commit Biologics
info@commitbio.com
Universitetsbyen 83 8000 Aarhus C, Denmark

Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration

Designation earned for a one-time intravitreal gene therapy with the potential to eliminate treatment burden for people living with neovascular age-related macular degeneration Neovascular or “wet” age-related macular degeneration can...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: September 11, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

New Anthem from Girl Band Raises Awareness of Type1 Diabetes After Research Highlights Silent Struggle

Recent research from Sanofi highlights the significant impact of Type 1 Diabetes on those living with the condition The song, “Rise Up,” shares their experiences of living with the condition...

Category: Other, Pharmaceutical
Posted: May 29, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria

Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placebo In the US, there are more than 300,000 adults and adolescents aged 12 years...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 18, 2025

Regeneron
ukinfo@regeneron.com
The Charter Building, Vine Street, Uxbridge, Middlesex, United Kingdom, UB8 1JG

Sanofi’s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD

New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthma Lunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthma Itepekimab expanding into chronic rhinosinusitis along with...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 15, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines

Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia.  3 April...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 3, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD

Following recent approvals in the EU, China, and the US, this approval was based on pivotal phase 3 results in adults with elevated eosinophils Approval marks the first new treatment...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: March 28, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Alys Pharmaceuticals Announces Dosing of First Patient in Phase IIa Trial of ALY-101 for Alopecia Areata

Unique siRNA platform, developed with Nobel Prize Laureate Craig Mello, offers potential for treating multiple dermatology indications ALY-101 is formulated as an intradermal injectable for the treatment of Alopecia Areata...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 27, 2025

Alys Pharmaceuticals
info@alyspharma.com
100 Northern Avenue Boston Massachusetts 02210, United States

Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis

If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity Tolebrutinib...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 25, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Sanofi to acquire Dren Bio’s bispecific myeloid cell engager for deep B-cell depletion, broadening immunology pipeline

Dren Bio deep B-cell depleter program has the potential to reset the immune system Acquisition underpins path for Sanofi becoming leading immunology company Sanofi to pay $600 million up front....

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 20, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Opella reaches study milestone for Cialis

21 January 2025 -- Paris, France -- Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual...

Category: Clinical Trials, Other, Pharmaceutical
Posted: January 21, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma

Approval based on positive pivotal ICARIA-MM phase 3 study using the China-based IsaFiRsT real-world study as bridging data, which demonstrated Sarclisa and the standard treatment Pd, improved responses and long-term...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 13, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

New Sarclisa subcutaneous formulation met co-primary endpoints in the IRAKLIA phase 3 study in multiple myeloma

Sarclisa SC formulation added to Pd for the treatment of R/R MM met the co-primary endpoints in the IRAKLIA phase 3 study, demonstrating non-inferiority compared to Sarclisa IV IRAKLIA is...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 9, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

ASH: Sarclisa combinations demonstrated significant benefits in newly diagnosed multiple myeloma patients

New analysis from the IMROZ phase 3 study of Sarclisa-VRd demonstrated higher and sustained MRD negativity rates in transplant-ineligible NDMM patients versus VRd alone New detailed results from the GMMG-HD7...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 9, 2024

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK