Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity
These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products
This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
NUFYMCO BLA has been approved by the USFDA
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026
Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies
Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The funding will support the pivotal Phase 3 clinical trial of neridronate in CRPS-1
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