April 26, 2023 03:48 PM EDT
R&D

Fol­low­ing CRL, Form 483 re­veals more qual­i­ty is­sues at Alvotech’s pro­duc­tion fa­cil­i­ty in Ice­land

Tyler Patchen

News Reporter

An­oth­er Form 483 for the Ice­landic biosim­i­lar man­u­fac­tur­er Alvotech’s man­u­fac­tur­ing fa­cil­i­ty has shed more light on a re­cent com­plete re­sponse let­ter from the FDA …

Endpoints News

Sign up to read this article for free.

Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.

BECOME A PREMIUM SUBSCRIBER
TRENDING NOW

The End­points 2024 win­ners and losers list: Who was up and who was down in bio­phar­ma

Up­dat­ed: No­vo’s 23% weight loss with Ca­griSe­ma falls short of high ex­pec­ta­tions, new tri­al planned

FDA ap­proves Hu­ma­cyte’s lab-grown blood ves­sels in mile­stone for re­gen­er­a­tive med­i­cine

Ac­cel­er­at­ed ap­proval brings Pfiz­er's BRAF in­hibitor to first-line pa­tients

Ex­clu­sive: Flori­da can­cer biotech rais­es $100M Se­ries A

Sofinno­va out­lines $550M fund af­ter IPOs and M&A deals

A service from the Financial Times