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Tuesday, July 02, 2024 2:37:45 PM
Pharma Stock Roundup: FDA's CRL to MRK & ABBV, Phase III Study Failures for NVO, AZN
Fri, Jun 28, 2024, 8:13 AM CDT
https://finance.yahoo.com/news/pharma-stock-roundup-fdas-crl-131300652.html
The FDA issued a complete response letter (“CRL”) to Merck and its partner Daiichi Sankyo’s
biologics license application (BLA) seeking accelerated approval for patritumab deruxtecan
for previously-treated EGFR-mutated non-small cell lung cancer (NSCLC). The CRL was based
on observations made after the inspection of a third-party manufacturing facility. The FDA
has not requested any additional efficacy/safety studies, nor has it identified any issues
related to the safety and efficacy of the candidate.
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