X4 Pharmaceuticals’ Xolremdi (Mavorixafor) Receives the CHMP Positive Opinion for WHIM Syndrome

Shots: The CHMP has recommended approval of Xolremdi, under exceptional circumstances, for the treatment of WHIM syndrome, with EC’s decision expected in Q2’26 Opinion was backed by the global P-III (4WHIM) trial assessing Xolremdi vs PBO in 31 pts (≥12yrs.) with WHIM syndrome, which showed improved absolute lymphocyte counts, absolute neutrophil counts, & fewer infections,…

ByRidhi RastogiMarch 2, 2026

Insights+: The US FDA New Drug Approvals in April 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of April 2024 The US FDA approved a total of 12 new drugs including 11 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was X4 Pharmaceuticals’ Xolremdi for…

ByDipanshu DixitMay 14, 2024

X4 Pharmaceuticals’ Xolremdi Receives the US FDA’s Approval for the Treatment of WHIM Syndrome

Shots: The US FDA has approved Xolremdi (mavorixafor) capsules for treating WHIM syndrome patients (12yrs. & above) and granted a Rare Pediatric Disease Priority Review Voucher to the company The approval was supported by the P-III (4WHIM) study assessing the safety & efficacy of Xolremdi vs PBO to treat WHIM syndrome patients (n=31, 12yrs. &…

ByDipanshu DixitApril 29, 2024

X4 Pharmaceuticals’ Xolremdi (Mavorixafor) Receives the CHMP Positive Opinion for WHIM Syndrome

Insights+: The US FDA New Drug Approvals in April 2024

X4 Pharmaceuticals’ Xolremdi Receives the US FDA’s Approval for the Treatment of WHIM Syndrome

Contact US

FOLLOW US