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What Does the Second FDA Rejection Mean for Replimune's RP1

3 months ago

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What Does FDA Clearance Mean for AI-Powered Diagnostics

2 months ago

What Does Ultragenyx's Latest FDA Clearance Mean for Investors

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What Does the FDA Warning Mean for Medline's Operations

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What Does Teva's Recent FDA Acceptance Mean for Investors

5 months ago

Replimune Announces FDA Acceptance of RP1 Biologics License Application Resubmission for Advanced Melanoma

Replimune's BLA resubmission for RP1 plus nivolumab in advanced melanoma was accepted for FDA review, after a prior rejection. A decision could come by late 2026.

REPL

Stock News•4 weeks ago

Immunocore: KIMMTRAK Is Becoming A Cash Engine For A Much Larger TCR Platform

Immunocore's KIMMTRAK global sales and five-year survival data fund a broad pipeline without dilutive equity. Upcoming catalysts include pivotal readouts for tebentafusp and brenetafusp in melanoma.

IMCR

Stock News•2 months ago

Regeneron Shares Slide Premarket after Melanoma Drug Trial Disappoints

Regeneron shares fell in premarket trading after the company announced that a late-stage clinical trial for its melanoma drug failed to meet primary endpoints. The setback raises uncertainty regarding...

REGN

Stock News•2 months ago

What's Going On With Replimune Stock On Tuesday?

Replimune shares are reacting to broader sector volatility following FDA Commissioner Marty Makary's CNBC interview on Tuesday. The discussion addressed mounting criticism regarding drug approval proc...

REPL