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Pharmalittle: We're reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China, and more

Pharma updates from the Pharmalot campus via the Pharmalittle newsletter

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statnews.comStai leggendo19 h fa

Pharmalittle: We're reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China,…

Pharma updates from the Pharmalot campus via the Pharmalittle newsletter

originale

endpoints.news18 h fa

Replimune to ask FDA for re-review of melanoma drug, as agency stands by past rejections

Replimune will resubmit advanced melanoma drug RP1 to the FDA after two rejections, following the ouster of Commissioner Marty Makary; shares jumped about 70%.

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biopharmadive.com1 g fa

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

Replimune files a third FDA application for RP1 (melanoma, 33% tumor response) after two rejections over 12 months. The ~80% stock surge signals a regulatory thaw at the FDA, whose unpredictability had been flagged as biotech's top investment headwind.

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Pharmalittle: We're reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China, and more

Confronto fonti

Pharmalittle: We're reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China,…

Replimune to ask FDA for re-review of melanoma drug, as agency stands by past rejections

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

Timeline cronologica

Pharmalittle: We're reading about a hepatitis B drug, CVS returns Lilly obesity drug to formularies, and more

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

Pharmalittle: We're reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China, and more

Replimune to ask FDA for re-review of melanoma drug, as agency stands by past rejections

Pharmalittle: We're reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China, and more

Confronto fonti

Pharmalittle: We're reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China,…

Replimune to ask FDA for re-review of melanoma drug, as agency stands by past rejections

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

Timeline cronologica

Pharmalittle: We're reading about a hepatitis B drug, CVS returns Lilly obesity drug to formularies, and more

Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks

Pharmalittle: We're reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China, and more

Replimune to ask FDA for re-review of melanoma drug, as agency stands by past rejections