AstraZeneca’s initial application for lupus injection turned down by FDA

The company is working with the U.S. regulator to move forward with an updated application, adding a decision is expected in ...
Healio

Sub-Tenon injection of mitomycin C may have advantages over sponge application

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 ...
Daily Local News

FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADITM (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

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 ...
Healio

FDA approves abbreviated new drug application for ganirelix acetate injection

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 ...
Seeking Alpha

Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application

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) ...