In a move towards transparency, the US Food and Drug Administration (FDA) has published more than 200 archived complete response letters (CRLs), which detail reasons for non-approval of drug ...

Increasing CRLs from the FDA highlight CMC and analytical deficiencies, often surfacing late in the review cycle, indicating a disconnect between sponsor expectations and FDA standards. Recent CRLs ...

In 2024, multiple drugs received complete response letters (CRLs), sometimes unrelated to the safety and efficacy of the drug, but patients with schizophrenia gained the first new treatment with a new ...

The FDA's decision to publish complete response letters (CRLs) amounted to little more than a repackaging of existing information, but now it has gone a step further. The latest batch of CRLs to be ...

The school’s boys’ soccer team is sending four students to the NCAA for the first time in program history. Last week, 15 ...

The release comes after years of back-and-forth about making CRLs public. The FDA has released an "initial batch" of more than 200 complete response letters (CRLs) in efforts to boost transparency.

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval ...

A CRL signifies non-approval of a drug/application in its current form, but allows for issue resolution and potential approval. In 2025, the FDA began publishing CRLs to enhance transparency, ...

Aldeyra is downgraded from Buy to Hold due to high risk ahead of reproxalap's December PDUFA for dry eye disease. ALDX faces regulatory uncertainty after two FDA CRLs, with recent mixed trial results ...