Zevra wins FDA panel backing for previously rejected arimoclomol
Reinforced with additional data, Zevra’s arimoclomol data package has gained a positive opinion in Niemann-Pick disease type C from an FDA advisory committee.
06 August 2024
06 August 2024
Reinforced with additional data, Zevra’s arimoclomol data package has gained a positive opinion in Niemann-Pick disease type C from an FDA advisory committee.
BioNTech has given Genmab full control of their joint PD-L1 therapy programme, as it recovers from Q2 losses.
The company had emerged from bankruptcy in November 2023 after reducing its total funded debt by $1.9bn.
Kerendia’s Phase III study met its primary endpoint by reducing the risk of cardiovascular death and heart failure.
The litigations began after the US FDA requested the removal of Zantac from the market in 2020.
Preclinical experiments have shown that META-001-PH can reduce urinary oxalate excretion by up to 80%.
Antengene has submitted NDAs for XPOVIO in Thailand and Indonesia, with approvals expected in the second half of 2024.
The deal will leverage SK pharmteco's expertise to transition from clinical to commercial-scale manufacturing of assets.
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