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news.BeOne’s sonrotoclax gains priority FDA review for mantle cell lymphoma
The decision is intended for those who have previously been treated with a Bruton’s tyrosine kinase (BTK) inhibitor. This application is based on data from a global, open-label,
The decision is intended for those who have previously been treated with a Bruton’s tyrosine kinase (BTK) inhibitor. This application is based on data from a global, open-label,
The approach is consistent with outpatient settings as per US Food and Drug Administration (FDA)-approved use. The initiative enhances access to non-oral diuretic therapy throughout CVL’s cardiovascular practice
The deal sets the vaccine price at $2.99 per dose and is expected to take effect within a year, supporting Gavi’s goal to fully vaccinate 50 million more
Voyxact is administered as a self-injected subcutaneous dose every four weeks. Its approval was based on the interim results of the Phase III VISIONARY trial, which demonstrated a
Cellergy will utilise the good manufacturing practices (GMP) expertise of Made Scientific to enhance its mitochondrial isolation and purification process for the clinical-grade production of CLG-001. This work
This therapy is intended for children aged two years and above, teens and adults with SMA who have a confirmed mutation in the survival motor neuron 1 (SMN1)
The investment covers both expansion of the Frederick biologics manufacturing facility and a new plant construction in Gaithersburg, targeting operational readiness by 2029. The Frederick site, which produces
The agreement includes an exclusivity period of six months for negotiating and finalising a definitive agreement, pending due diligence and board approvals. Vaximm is eligible for an upfront
This round will also bolster the company’s manufacturing offerings and support additional pipeline therapies. It was jointly led by OrbiMed, Frazier Life Sciences, ARCH Venture Partners and Revelation
The authorisations cover Gobivaz in both 100mg/ml and 50mg/0.5ml formulations, provided in pre-filled syringes with autoinjector formats and passive needle safety guards, to treat adults with axial spondyloarthritis,