News about "Sanofi"

Sanofi Warns of Near-Term Weakness in US Vaccine Demand Amid Antivax Rhetoric

French pharmaceutical company Sanofi expects near-term weakness in vaccine sales in the United States, attributing the anticipated softness to growing scepticism around immunizations that the company says has been fueled by misinformation.

Sanofi | 15/01/2026 | By Darshana |  123

US FDA Advances Review of Tzield in Young Children

The FDA has accepted Sanofi’s sBLA for Tzield under priority review, seeking broader pediatric use in delaying type 1 diabetes onset.

Sanofi | 06/01/2026 | By News Bureau

Tiziana Submits Annual Safety Report for Intranasal Foralumab to FDA

Tiziana has submitted its annual safety report for intranasal foralumab to the US FDA, reporting an excellent safety profile based on 37.4 cumulative patient-years of exposure and highlighting the continued need for safer therapies following the FDA’s denial of Sanofi’s tolebrutinib for non-relapsing secondary progressive multiple sclerosis.

Sanofi | 30/12/2025 | By News Bureau

Sanofi to Acquire Dynavax, Expanding Vaccine Portfolio

Sanofi has agreed to acquire Dynavax, strengthening its adult immunisation portfolio with an approved hepatitis B vaccine and a shingles vaccine candidate in phase I/II development. The deal combines Dynavax’s vaccine assets with Sanofi’s global development and commercial capabilities.

Sanofi | 24/12/2025 | By News Bureau

EU Approves Sanofi's Wayrilz as First BTK Inhibitor for Immune Thrombocytopenia

Sanofi has received EU approval for Wayrilz, the first Bruton’s Tyrosine Kinase (BTK) inhibitor indicated for immune thrombocytopenia, offering a novel multi-immune modulation approach. The approval is based on positive results from LUNA 3 study, which demonstrated rapid and durable platelet responses.

Sanofi | 24/12/2025 | By News Bureau

Sanofi and Novartis Reach Separate Agreements with US Government to Lower Drug Prices and Support Innovation

Sanofi and Novartis have separately entered into agreements with the US government to reduce medicine prices for American patients while reinforcing long-term commitments to US-based manufacturing, research and innovation, marking a coordinated push to balance affordability with sustained pharmaceutical investment.

Sanofi | 22/12/2025 | By News Bureau |  116

Sanofi's Efdoralprin Alfa Gains EU Orphan Designation for AATD Emphysema

Sanofi’s investigational restorative recombinant therapy efdoralprin alfa has received EU orphan drug designation for alpha-1 antitrypsin deficiency–related emphysema, following positive phase II head-to-head results demonstrating success across all primary and key secondary endpoints versus the current plasma-derived standard of care.

Sanofi | 20/12/2025 | By News Bureau

ADEL Signs USD 1.04 Billion Global Licensing Deal with Sanofi for Alzheimer's Drug

ADEL has signed a global licensing deal with Sanofi for its investigational Alzheimer’s therapy ADEL-Y01, valued at up to USD 1.04 billion, including a USD 80 million upfront payment, milestone payments and royalties.

Sanofi | 16/12/2025 | By News Bureau

State of Texas Sues Bristol-Myers Squibb, Sanofi Over Alleged Failure to Disclose Plavix Efficacy

McKool Smith and The Lanier Law Firm, along with Texas Attorney General Ken Paxton, have filed a lawsuit on behalf of the State of Texas against Bristol-Myers Squibb Company and several Sanofi entities, alleging the companies failed to disclose the efficacy and safety profile of the drug Plavix, which is used as a blood thinner.

Sanofi | 21/11/2025 | By Dineshwori

CHMP Recommends Sanofi's Tezeild for EU Approval in Stage 2 Type 1 Diabetes

The CHMP has backed EU approval for Sanofi’s Tezeild, supported by TN-10 study results showing the therapy can delay progression to stage 3 type 1 diabetes in patients with stage 2 disease. If authorised, Tezeild would become the first disease-modifying treatment for T1D in the EU.

Sanofi | 15/11/2025 | By Dineshwori |  241