Sanofi’s Rilzabrutinib Secures the EMA’s Orphan Drug Designation to Treat IgG4-Related Disease

Shots: The EMA has granted ODD to rilzabrutinib for the treatment of IgG4-related disease (IgG4-RD) Rilzabrutinib (PO) is being evaluated in a P-II trial for IgG4-RD with glucocorticoids vs glucocorticoids alone, showing reduced flares, improved disease markers, & steroid sparing over 52 weeks; data presented at EULAR 2025 Rilzabrutinib, a reversible covalent BTK inhibitor, is…

ByRidhi RastogiAugust 14, 2025

The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

Shots: The US FDA has granted FTD to Birelentinib (DZD8586) for the treatment of adults with r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received ≥2L of therapy, incl. a BTK & a BCL-2 inhibitor Designation was based on pooled P-I/II data showing 84.2% ORR & DoR rate of 83.3% at 9mos.…

ByRidhi RastogiAugust 8, 2025

BeOne Receives CHMP Positive Opinion for New Brukinsa Tablet Formulation Across All Approved Indications

Shots: Following the US FDA approval, EMA's CHMP issued a positive opinion of Brukinsa (zanubrutinib) film‑coated tablets for all approved indications. EC will now review the opinion for MAA in the EU, Norway, and Iceland BRUKINSA tablets (160mg) are bioequivalent to the capsule form, supported by a P-I study. With a recommended daily dose of 320mg,…

ByDipanshu DixitJune 27, 2025

The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

BeOne Receives CHMP Positive Opinion for New Brukinsa Tablet Formulation Across All Approved Indications

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