Complete Response Letter

Delayed on hold
Biotech

Vanda sues FDA over months-long hearing delay

Vanda says CDER “has asked the commissioner to allow it to take six months to merely respond to Vanda’s request for a hearing."
Gabrielle Masson Apr 23, 2025 10:33am
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Aldeyra’s dry eye drug suffers second FDA rejection

Apr 3, 2025 8:46am
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FDA hits Zealand Pharma's Gattex challenger with CRL

Dec 19, 2024 4:22pm
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FDA rejects Applied filing for rare disease approval

Dec 2, 2024 5:27am
showdown clash versus vs crash lightning fight dispute

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