European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. This conclusion was based on the same data submitted to the FDA.

Food and Drug Administration 52

Food and Drug Administration Medicine FDA Marketing 52

PM360

JULY 13, 2023

The FDA has granted Fast Track Designation for our HER2-targeted ADC, ARX788, and we are enrolling the signal-seeking ACE-Breast-03 Phase 2 clinical study in post-Enhertu mBC patients throughout 2H 2023. Not only can we design drugs better, but we can understand their effects better to engineer small molecules in a more efficient way.

Patients 98

Patients Engineering Side effects Leads 98

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

Food and Drug Administration 75

Food and Drug Administration Safety Patients Leads 75