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REPL Stock Rises on FDA's Priority Review for Melanoma Drug BLA
Replimune Group, Inc. REPL announced that the FDA has accepted the biologics license application (BLA) for its lead pipeline ...
Replimune stock soars on FDA priority review for melanoma treatment
Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug ...
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...
Healio12d
FDA grants priority review to nipocalimab for myasthenia gravis
The FDA has granted priority review to a Biologics License Application for nipocalimab to treat individuals with generalized ...
Datopotamab Deruxtecan Granted Priority Review in the U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab ...
Johnson & Johnson Gets FDA Priority Review of Nipocalimab in Generalized Myasthenia Gravis
Johnson & Johnson has won Food and Drug Administration priority review for its application seeking approval of nipocalimab in certain patients with generalized myasthenia gravis.
SpringWorks: PDUFA Review Date Could Lead To Next Approved Pipeline Candidate
SpringWorks has shown strong revenue growth with OGSIVEO, achieving a 23% increase from Q2 of 2024 to Q3 of 2024. See why I ...
Cure Today8d
FDA Grants Priority Review to Sunvozertinib for EGFR Exon20+ NSCLC
The Food and Drug Administration has accepted and granted priority review to a new drug application for sunvozertinib.
Monthly Prescribing Reference9d
Datopotamab Deruxtecan Gets Priority Review For Advanced EGFR-Mutated NSCLC
The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) for the treatment of adults with locally advanced ...
Monthly Prescribing Reference13d
Nipocalimab Gets Priority Review for Generalized Myasthenia Gravis
The application is supported by data from the randomized, double-blind, placebo-controlled phase 3 Vivacity-MG3 study.
Morningstar10d
Datopotamab deruxtecan granted Priority Review in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer
AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the US for the treatment of adult ...