Complete Response Letter

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Pharma

Celltrion buy, Rexulti CRL, Glenmark-Hengrui—Fierce Pharma Asia

Celltrion bought a Lilly plant in the U.S. The FDA turned down Lundbeck and Otsuka's PTSD application. Hengrui and Glenmark signed an ADC deal.
Angus Liu Sep 26, 2025 10:00am
Biogen

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

Sep 24, 2025 9:51am
red light stoplight

Issues at Novo site delay Scholar Rock's bid for SMA approval

Sep 23, 2025 9:19am
Graphic image of a red thumbs down against a blue background

Otsuka, Lundbeck's Rexulti snubbed by FDA in PTSD

Sep 22, 2025 4:42pm
FDA
Favicon Fierce Biotech

FDA plans real-time release of drug rejection letters

Sep 4, 2025 1:45pm
FDA stop sign

Outlook stock plummets as FDA again snubs wet AMD drug

Aug 28, 2025 10:55am