Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

Shots:The CHMP has recommended Wayrilz (rilzabrutinib) for adults with ITP unresponsive to other treatments, with a final decision expected soon; under regulatory review for ITP in ChinaOpinion was based on the P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO during a 12–24-wk, followed by 28 wks, and then a four-week…

ByDipanshu Dixit4 days ago

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Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Shots:The US FDA has approved Rhapsido for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Regulatory filings are also made in the EU, Japan & China, with priority review granted in ChinaApproval was backed by P-III (REMIX-1 & 2) trials in CSU, which showed improved…

ByRidhi RastogiOctober 1, 2025

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Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)

Shots:FDA has approved Wayrilz for adults with persistent or chronic ITP who did not respond adequately to prior therapy following approval in UAE in Jun 2025; Application under the EMA & NMPA's reviewApproval was based on P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO in adults (n=202) with ITP over…

ByRidhi RastogiSeptember 1, 2025

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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 2025Rilzabrutinib, a reversible covalent BTK inhibitor, is…

ByRidhi RastogiAugust 14, 2025

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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 inhibitorDesignation was based on pooled P-I/II data showing 84.2% ORR & DoR rate of 83.3% at 9mos.…

ByRidhi RastogiAugust 8, 2025

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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 IcelandBRUKINSA 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

Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)

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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