21 December 2023
21 December 2023
The regulatory authority granted the approval based on findings from the Phase III NefIgArd clinical trial.
Despite approvals in Europe and Japan, the FDA rejected the oral drug, citing a lack of substantial evidence for treatment effectiveness.
By cutting programs and 46% of staff, Aclaris becomes the latest company to implement restructuring measures in a bid to free capital.
The European Commission (EC) has revoked marketing authorisations for Tecfidera generics, granting the drug marketing protection until February 2025.
In preclinical research, OCE produced a decline in portal hypertension and amelioration of ascites volume.
Bluebird bio will secure up to $250m after a surprise decision from the US Food and Drug Administration (FDA) to hold back a priority review voucher.
The deal grants GSK the rights to develop and commercialise the ADC worldwide, excluding mainland China, Taiwan, Hong Kong and Macau.
The company’s One-Bac 4.0 system guarantees safety by reducing impurities and eliminating replication-competent adeno-associated virus (AAV).
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