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SECAUCUS, N.J., Jan. 12, 2026 /PRNewswire/ -- On January 9, 2026, Pierre Fabre Pharmaceuticals, Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) stating ...

NEW YORK – The US Food and Drug Administration has issued a complete response letter, declining to approve Pierre Fabre Pharmaceuticals' biological license application for the allogenic T-cell ...

Can Pathologic Complete Response Serve as a Valid Surrogate End Point? The following represents disclosure information provided by authors of this manuscript. All relationships are considered ...

1 Ultrasound Department, Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, ...

Python’s popularity is surging. In 2025, it achieved a record 26.14% TIOBE index rating, the highest any language has ever reached, largely driven by AI and data trends. 58% of developers now use ...

We retrospectively reviewed medical records of patients with mGC/GEJC who received systemic chemotherapy at our institute between April 2013 and March 2022. Patients were defined as having a potential ...

The treatment effects on PFS were consistent regardless of modeling approach and for both targeted and nontargeted therapies. Achieving complete response/remission (CR) is a reasonable surrogate ...

Bladder squamous cell carcinoma (SCC) is a rare histological subtype of bladder cancer (1%–5% of cases), with radical cystectomy as the primary recommended treatment. However, evidence for neoadjuvant ...

The FDA issued a complete response letter for SYD-101, citing insufficient evidence of effectiveness despite achieving primary efficacy in the STAR trial. The STAR trial demonstrated significant ...

How cell and gene therapy developers can lessen the chances of receiving FDA complete response letters through the use of proactive chemistry, manufacturing, and controls strategies. The growth of ...