News and Press Releases

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

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Fondazione Telethon Submits US Biological License Application for Etuvetidigene Autotemcel Gene Therapy for the Treatment of Wiskott-Aldrich Sydrome

11 March 2025 -- Milan, Italy -- Fondazione Telethon, an Italian biomedical charity focused on rare genetic diseases, announced that it has submitted the Biologics License Application (BLA) for the...

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

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OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain

10 March 2025 -- London, UK and New York, US -- OKYO Pharma Limited, a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain, a severe...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 10, 2025

OKYO Pharma Floor 4, 14/15 Conduit St London W1S 2XJ

Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe

FDA, EMA grant BIOX-101 ODD status to treat intracerebral hemorrhagic stroke (ICH) ODD status may expedite drug candidate development and approvals BIOX-101 interim Phase 2a data in ICH imminent. 5...

Category: Drug Discovery, Other, Pharmaceutical
Posted: March 5, 2025

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Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial

4 March 2025 -- New York, US -- Tiziana Life Sciences, Ltd, a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 4, 2025

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Boehringer’s nerandomilast meets primary endpoint in Phase III study FIBRONEER-ILD, in progressive pulmonary fibrosis

Topline data from FIBRONEER™-ILD show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in forced vital capacity [mL] at week 52 versus...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 10, 2025

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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

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PulseSight Therapeutics announces the initiation of the clinical plan of PST-611, Transferrin Vectorized Therapy for dry AMD/Geographic Atrophy

14 January 2025 -- Paris, France -- PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, today announces it has submitted a Clinical...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: January 14, 2025

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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

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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

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PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML)

Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of LYT-200 to serve broad range of patients across various lines of treatment LYT-200...

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

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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

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ASH: rilzabrutinib demonstrated significant patient benefit in the first positive phase 3 study of a BTK inhibitor in ITP

Pivotal phase 3 data show rapid and durable platelet response, reduced bleeding and need for rescue response, and improved physical fatigue and quality of life measures in patients with persistent...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: December 7, 2024

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Sanofi launches high-dose egg-based quadrivalent influenza vaccine (QIV-HD) in the UK

Developed with a higher antigen content to increase protection in older adults, a population at greater risk of severe complications from infection. Now available and can be pre-ordered for the...

Category: Pharmaceutical
Posted: October 17, 2024

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Sanofi and Orano join forces to develop next-generation radioligand medicines

17 October 2024 -- Paris, France -- Sanofi and Orano Med, a subsidiary of the Orano Group and a pioneer in the development of targeted alphatherapies in oncology, have entered...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 17, 2024

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