Complete Response Letter

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FDA rejects Regeneron bispecific, delaying rival to J&J, Pfizer

The FDA hit the Big Biotech's BCMAxCD3 bispecific antibody linvoseltamab with a complete response letter over issues at a third-party manufacturer.

Nick Paul Taylor Aug 21, 2024 5:48am

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Lykos' MDMA treatment for PTSD has been quashed at the FDA

Aug 10, 2024 9:07am

eye drops

Aldeyra preps for FDA refiling as dry eye drug hits ph. 3 goal

Aug 8, 2024 10:48am

rocket launch satellite space fly blast off

Rocket gene therapy's flight to approval delayed by FDA

Jun 28, 2024 9:58am

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Milestone resubmits NDA, Aldeyra readies 2nd chance filing

Mar 28, 2024 10:40am

Stop sign

FDA blocks approval of Regeneron's blood cancer drug

Mar 25, 2024 9:25pm