FDA setback for Sanofi’s Tolebrutinib in progressive MS
Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity
Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity
Indian Pharmacopoeia is now recognised in 19 countries, reflecting growing international confidence in India’s regulatory and scientific capabilities
Masitinib targets mast cells, which play a critical role in severe forms of SCD and its complications, including vaso-occlusive crises, acute chest syndrome, and pain
The move strengthens Sanofi’s presence in adult immunization by combining Dynavax’s innovative vaccines with Sanofi’s global scale and development capabilities
The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies
BBIL will guarantee production and supply of MTBVAC to more than 70 countries across Africa and Southeast Asia
The new single-use commercial facility will be among India’s largest, featuring advanced technologies to produce high-quality biologics and specialty pharmaceuticals
Under the terms of the deal, AstraZeneca gains exclusive rights to JAB-23E73 outside of mainland China
The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo
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