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FDA, RP1 and Nivolumab

BLA Accepted for Melanoma Combination Therapy, RP1 and Nivolumab

The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22, 2025.

Hosted on MSN · 2d

FDA accepts Replimune's advanced melanoma therapy BLA

Replimune Group Inc (NASDAQ: NASDAQ:REPL), a biotech firm focused on oncolytic immunotherapies, announced today that its Biologics License Application (BLA) for RP1 in combination with nivolumab has been accepted by the U.

Targeted Oncology · 1d

FDA Accepts BLA for RP1 With Nivolumab in Advanced Melanoma

The biologics license application for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma was accepted by the FDA with priority review.

Business Insider · 2d

Replimune's BLA For RP1-Nivolumab Combo Gets FDA Approval For Advanced Melanoma, Stock Surges

Following the announcement, Replimune's stock is currently climbing 26.09 percent, to $12.78 on the Nasdaq. Replimune said RP1 is intended to maximize tumor-killing potency, the immunogenicity of tumor cell death,

Zacks.com on MSN · 23h

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 candidate, RP1 (vusolimogene oderparepvec), in combination with Bristol Myers’ BMY Opdivo (nivolumab) to treat adult patients with advanced melanoma.

Australian research makes breakthrough in boosting breast cancer cure rate

Australian researchers have made a breakthrough in improving the cure rate for the most common form of breast cancer. An ...

Healio12d

Adjuvant nivolumab improves DFS in high-risk head and neck cancer

The addition of adjuvant nivolumab to standard-of-care radiotherapy and cisplatin improved survival for patients with locally ...

Medscape10h

How New Research Is Redefining Melanoma Treatment

Research has introduced daromun, therapeutic vaccines, and novel combinations for metastatic melanoma, reshaping the ...

Targeted Oncology17h

Beckermann and Participants Discuss Second-Line ccRCC Options

During a Case-Based Roundtable® event, Kathryn E. Beckermann, MD, PhD, discussed second-line regimens with event participants ...

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 ...

oncnursingnews7dOpinion

Opinion: Subcutaneous Nivolumab Offers an Effective Alternative to Intravenous Administration

Oncology nurses can educate patients on the benefits of subcutaneous administration, including reduced time in the infusion ...

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