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Two CRLs from the FDA last week cited concerns with third-party manufacturers, while Indian CDMOs may make a bid for U.S. business if there is a decoupling from Chinese companies under the BIOSECURE Act. https://hubs.li/Q02Ff_tc0

FDA Approves Lilly’s Donanemab While Rejections Highlight Manufacturing Issues | BioSpace

FDA Approves Lilly’s Donanemab While Rejections Highlight Manufacturing Issues | BioSpace

biospace.com

Interesting developments in the pharma industry landscape. The potential shift to Indian CDMOs could reshape manufacturing dynamics amid regulatory changes.

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