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10 Approvals To Look Out For In Q3 2023

 
• By Alexandra Shimmings

The third quarter could bring US approvals for a range of novel drugs, including the first treatment for a common eye disease, the first US approval of PD-1/L1 inhibitor from a Chinese firm, and the first oral therapy for postpartum depression.

• Source: Shutterstock

PDUFA for NDA - Second Review 24 July

Despite launching the product as Vanflyta in 2019, Daiichi Sankyo Co., Ltd. has been waiting a long time for US approval of quizartinib, its oral FLT3 kinase inhibitor, for...

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ASCO: J&J Banks On T-Cell Engager’s Safety In Prostate Cancer

 
• By Andrew McConaghie

The company highlighted the KLK2-targeting agent’s safety at ASCO but it may have to rely on combinations to make pasritamig competitive.

ASCO: Regeneron Looks To Become Bigger Immuno-Oncology Player

 
• By Alaric DeArment

The drugmaker presented oral abstracts at the meeting for Libtayo in adjuvant cutaneous squamous-cell carcinoma and linvoseltamab in multiple myeloma.

ASCO: Lupin Presents Early Data On PRMT5 Inhibitor

 
• By Vibha Ravi

ASCO sees the debut of Lupin’s PRMT5 inhibitor candidate LRNP7457, currently in Phase I studies in India. While no drug with this mechanism of action has been approved anywhere so far, several candidates are in clinical trials.