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FDA, Replimune

MedCity News · 17h

Recovery for Replimune: Accelerated Approval for Cancer Drug Twice Spurned by FDA

Replimune went from an FDA rejection to a resubmission, a positive advisory committee vote, and finally an accelerated regulatory approval for advanced melanoma — all in less than four months. The FDA nod for Replimune’s oncolytic viral therapy,

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Fierce Pharma · 1d

UPDATED: Replimune secures FDA approval for melanoma therapy Tudriqev after long regulatory battle

BioPharma Dive · 1d

Replimune rebounds to win FDA approval of melanoma drug

1d

FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma

The U.S. Food and Drug Administration today granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a ...

1d

REPL Stock Slumps 11% After-Hours — What’s Driving The Selloff?

Replimune said the U.S. Food and Drug Administration granted accelerated approval for TUDRIQEV, previously known as RP1, in ...

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