The company is working with the U.S. regulator to move forward with an updated application, adding a decision is expected in ...
We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. Sub-Tenon injection of mitomycin C may be an alternative ...
PLYMOUTH MEETING, Pa., June 26, 2021 /PRNewswire/ — Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injection for subcutaneous ...
Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. In this episode, Thomas Betts chats with ...
Please provide your email address to receive an email when new articles are posted on . Amphastar Pharmaceuticals received FDA approval of its abbreviated new drug application for ganirelix acetate ...
TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) ...
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