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

9 hours ago

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What Does Ultragenyx's Latest FDA Clearance Mean for Investors

1 week ago

What Does Teva's Recent FDA Acceptance Mean for Investors

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What Does the FDA's Priority Review Mean for Savara's MOLBREEVI

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What Does YUVIWEL's FDA Approval Mean for Ascendis Pharma

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Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma

Replimune Group received a complete response letter (CRL) from the FDA regarding its Biologics License Application for RP1 in combination with nivolumab. The regulatory setback delays the potential ap...

REPL

Stock News•1 months ago

FDA reversals leave investors worrying about the fates of other experimental drugs

The FDA denied or discouraged applications for at least eight new drugs in the past year, according to RTW Investments. This regulatory uncertainty may impact investor confidence regarding other exper...

DNLI

Stock News•1 months ago

Sr. FDA official calls Uniqure's Huntington's disease treatment a failure

A senior FDA official labeled Uniqure's experimental Huntington's disease treatment a "failed product" on Thursday, casting doubt on the gene therapy's future prospects.

QURE

Stock News•1 months ago

Theravance plans strategic review, including possible sale, after drug trial failure

Theravance Biopharma initiated a strategic review, potentially including a sale, following its experimental drug's failure to meet the primary endpoint in a late-stage blood pressure trial.

TBPH