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Biophytis has Requested a Pre-Submission Meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the Treatment of COVID-19

Biophytis SA announced that it has filed for a pre-submission meeting request with the Food and Drug Administration to discuss filing for Emergency Use Authorization in the United States for Sarconeos in the treatment of severe forms of COVID-19.

Biophytis has Requested a Pre-Submission Meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the Treatment of COVID-19 Read More »

Latest analysis of lecanemab’s effect on biomarkers as well as new data on subcutaneous dosing presented at the AAIC 2023 Alzheimer conference

BioArctic AB’s partner Eisai announced that the results of a detailed analysis of the Phase 3 Clarity AD study, presented at the Alzheimer’s Association International Conference 2023, demonstrated that lecanemab-irmb treatment showed benefits on both amyloid-beta and tau pathology as well as other downstream biomarker changes.

Latest analysis of lecanemab’s effect on biomarkers as well as new data on subcutaneous dosing presented at the AAIC 2023 Alzheimer conference Read More »

Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application for Toripalimab as the First-line Treatment of Extensive-stage Small Cell Lung Cancer

Shanghai Junshi Biosciences Co., Ltd announced that the supplemental new drug application for toripalimab, the company’s anti-PD-1 monoclonal antibody, in combination with etoposide plus platinum for the first-line treatment of patients with extensive-stage small cell lung cancer, has been accepted for review by the National Medical Products Administration.

Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application for Toripalimab as the First-line Treatment of Extensive-stage Small Cell Lung Cancer Read More »

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