Tag

Resubmission

All articles tagged with #resubmission

healthcare1 month ago•30 min saved

Aquestive gears up for Q3 resubmission after FDA CRL on Anaphylm

Aquestive Therapeutics received an FDA Complete Response Letter for Anaphylm Sublingual Film, with deficiencies limited to human factors and a required PK study; no CMC or broad safety issues were raised. The company plans to revise packaging/instructions, conduct a new HF validation and a PK study in parallel, and target resubmission in Q3 2026. Global filings in Europe and Canada are expected in 2026 as well, and the company remains well-capitalized to support approval and pre-launch activities.

via Stock Titan|

#anaphylm #fda-complete-response-letter #healthcare

health2 years ago•0 min saved

Checkpoint Therapeutics' Skin Cancer Therapy Rejected by FDA, Stock Plummets

The U.S. Food and Drug Administration (FDA) has declined to approve Checkpoint Therapeutics' experimental therapy, Cosibelimab, for the treatment of advanced skin cancer due to issues with a third-party contract manufacturer. The FDA did not express concerns about the drug's data or safety in its response letter. Checkpoint Therapeutics plans to address the feedback and resubmit the therapy for marketing approval in 2024. The trial data showed that Cosibelimab helped reduce or clear cancerous tumors by 47.4%.

via Yahoo Finance|

#checkpoint-therapeutics #cosibelimab #fda