The Food and Drug Administration on Thursday shared a strategic plan to completely eliminate the agency’s backlog of orphan drug designation requests. The plan comes a week after FDA Commissioner ...
Cipla clarified that its supply partner Pharmathen received nine USFDA Form 483 observations during a November 2025 inspection of its Greece facility for Lanreotide Injection, and the company is ...
Eugia remains under FDA scrutiny as the unit of Indian drugmaker Aurobindo has received its fifth Form 483 since December. The company’s latest slap from the U.S. regulator stems from an April 25 to ...
Pharmaceutical Technology on MSN
Atara receives FDA complete response letter for Ebvallo BLA application
The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
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