08 December 2023
08 December 2023
The FDA draft guidance on diabetes efficacy endpoints has elicited positive response, but stakeholders and experts stress reasonability.
The interim analysis data showed that the Sarclisa regimen offered statistically significant PFS improvement versus VRd alone.
In a third interim analysis, Keytruda plus Lynparza regimen did not show improvement in overall survival in NSCLC patients.
Pitolisant offered a clinically meaningful improvement in excessive daytime sleepiness, a primary efficacy endpoint of the trial.
Following the dosing of the first patient in Phase II atopic dermatitis trial, Kymera received a $15m milestone payment from Sanofi as part of the global licensing agreement.
The Phase II trial of HT-6184 will enrol around 50 patients with MDS who are or are on the borderline of being transfusion-dependent.
The device, which is already CE marked, could join a US vascular stent market expected to reach $2bn by 2033.
The open-label, randomised trial will enrol 330 adult and adolescent subjects aged 15 years and above.
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