BLA, FDA and RP1

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.
Replimune announces BLA acceptance, priority review for RP1
Group announced that the U.S. Food and Drug Administration, FDA, has accepted the Biologics License Application, BLA, for RP1
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.
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.
Replimune's BLA For RP1-Nivolumab Combo Gets FDA Approval For Advanced Melanoma, Stock Surges
(RTTNews) - Replimune Group, Inc. (REPL), Tuesday announced that the U.S. Food and Drug Administration has accepted the Biologics License Application for RP1 in combination with Nivolumab for the treatment of advanced melanoma. Following the announcement, Replimune's stock is currently climbing 26.09 percent, to $12.78 on the Nasdaq.
Managed Healthcare Executive2h
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 ...
MeiraGTx: 2 Possible Near-Term BLA Filings Could Ignite Shareholder Value
MeiraGTx's financials show $125 million in cash, but additional funding will be needed within the next 12 months. Click for ...
Asian News International17d
BLA claims 47 security personnel killed, over 30 others injured in attack on Pakistani army convoy in Turbat
In a statement, BLA spokesperson Jeeyand Baloch said that the attack took place in the Behman area, which is located some ...
Avidity Biosciences Plans First BLA Submission and Accelerates Commercialization Preparations for Three Rare Muscle Disease Programs in 2025
Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics ...
Shoals Technologies: A Great Risk-Reward Play Right Now
Shoals Technologies Group, Inc. offers a top risk-reward profile in the solar sector with creative solutions and good ...
Dunya News11d
BLA's looting in Zehri Bazaar, Kolpur reveals their desperation, resorting to theft after losing ground
QUETTA (Web Desk) - Ransacking banks, robbing locals, and targeting public buildings expose BLA’s anti-people, anti-progress, ...
Sportskeeda1d
“Bla bla bla… carry on” - When Lionel Messi’s father hit back at backlash over son winning Ballon d’Or ahead of Cristiano Ronaldo
Lionel Messi's father Jorge Messi once reponded to backlash over his son winning the Ballon d'Or ahead of Cristiano Ronaldo.
Zacks.com on MSN5d
ATRA Stock Down After FDA Issues CRL for Rare Blood Cancer Candidate
Shares of Atara Biotherapeutics ATRA plunged 40.5% on Thursday after the FDA issued a complete response letter (CRL) against ...