Form 483

FDA
Pharma

2 FDA citations trouble Hengrui, Elevar’s liver cancer combo

Following resolution of the problem cited in the CRL, investors questioned why the FDA issued a swift rejection instead of waiting for the PDUFA date.
Angus Liu Jul 28, 2026 3:02pm
FDA

Novo, Alvotech written up after FDA site inspections

Jul 17, 2026 10:56am
hiring new hire

Huahai poaches quality chief from Hengrui amid FDA citations

Jul 16, 2026 4:11pm
FDA

FDA issues Form 483 to Dr. Reddy's plant in India

Jun 26, 2026 11:40am
FDA

FDA clarifies Form 483 expectations after production inspections

May 1, 2026 10:52am
Catalent rebrand Catalent HQ Tampa Florida FL new Catalent HQ headquarters

FDA hit Catalent's Maryland manufacturing sites with Form 483

Dec 19, 2025 11:36am