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- Replimune takes third swing at cancer drug approval following ‘productive’ FDA talksA twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance following the resignation of former commissioner Marty Makary.BioPharma Dive · 2mo ago↗ source
- AstraZeneca seeks path for failed antibody; Imfinzi, Tremfya get label expansions🔎 AstraZeneca narrows path for failed antibody: The company announced last summer that its monoclonal antibody anselamimab missed the primary endpoint in a pair of Phase 3 trials for patients with…Endpoints · 2mo ago↗ source
- Replimune will again submit its melanoma drug for approvalThird time’s the charm? Replimune announced Friday that it will submit its advanced melanoma drug RP1 for FDA review after two prior rejections. It said it has had new discussions with ...