Complete Response Letter

rare diseases
Biotech

Stealth CEO questions FDA rejection of rare disease drug

“We are kind of hanging on by our fingernails here to try to bring this drug to the patient community,” Stealth CEO Reenie McCarthy told Fierce Biotech.
Gabrielle Masson May 29, 2025 2:27pm
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Stealth hit by FDA rejection to twice-delayed filing

May 29, 2025 7:46am
Delayed on hold

Vanda sues FDA over months-long hearing delay

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