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Y-mAbs Therapeutics Inc.

http://www.ymabs.com/

Latest From Y-mAbs Therapeutics Inc.

Breakdowns In The Breakthrough Lane: When Recipients Of FDA Expedited Designation Fall Short

Safety signals were the most common cause of discontinued candidates in the breakthrough therapy designation program in 2023.

US FDA Performance Tracker Drug Review

Finance Watch: Sun Shines On Biotech Stocks As J.P. Morgan Ends

Public Company Edition: Also, Johnson & Johnson’s consumer health spin-out Kenvue filed paperwork to get the ball rolling on an initial public offering. In addition, Geron raised $198m and Madrigal accessed more than $300m after positive trial readouts, but layoffs were revealed by Editas, Elevation, Nabriva and others.

Financing Restructuring

Rare Disease Patients: Placebo Controls, Sham Surgeries Not Appropriate For Gene Therapy Trials

Advocates also worry that long follow-up times could prevent participation in future clinical trials.

Clinical Trials Gene Therapy

Etranacogene Dezaparvovec, Omburtamab & Tremelimumab Await EMA Verdict

Four of the six products up for a marketing authorization opinion from the EMA’s advisory committee, the CHMP, this week are orphan drugs. One of them, omburtamab, was recently turned down by a US FDA advisory panel.

Europe Approvals
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