AbbVie (ABBV) said it has received a Complete Response Letter from the FDA for the New Drug Application for ABBV-951 for the treatment of motor fluctuations in adults with advanced Parkinson's disease. The FDA cited observations that were identified during inspection of a third-party manufacturer listed in the New Drug Application.
The company noted that the inspection at the facility did not involve ABBV-951 or any AbbVie medicine. AbbVie stated that the CRL does not request that AbbVie conduct additional efficacy and safety trials related to the drug or device-related testing.
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Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.