FDA rejection

Pharma

Biogen undeterred after FDA snub for high-dose Spinraza in SMA

Despite possessing solid data on high-dose Sprinraza in spinal muscular atrophy, Biogen must revise its application if it hopes to secure an approval.

Fraiser Kansteiner Sep 24, 2025 9:51am

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Otsuka, Lundbeck's Rexulti snubbed by FDA in PTSD

Sep 22, 2025 4:42pm

FDA's response letter salvo sheds light on drug refusal process

Jul 11, 2025 10:15am

Regeneron's Eylea franchise stumbles on several fronts in Q1

Apr 29, 2025 2:50pm

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Lexicon gets final FDA rejection for diabetes prospect

Dec 23, 2024 11:20am

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J&J, AZ approval filings rejected by FDA

Dec 17, 2024 10:02am