Complete Response Letter

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Biotech

FDA hits Zealand Pharma's Gattex challenger with CRL

In the FDA’s complete response letter, the agency recommended another clinical trial to provide more data for glepaglutide’s efficacy and safety.

Gabrielle Masson Dec 19, 2024 4:22pm

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FDA rejects Applied filing for rare disease approval

Dec 2, 2024 5:27am

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Vanda receives FDA rejection, issues fiery response

Sep 19, 2024 8:02am

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

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