Medicis Pharmaceutical Corp. (MRX) revealed in an SEC filing that it has received FDA letter stating that, upon preliminary review of the company's Biologics License Application, or BLA, for the botulinum toxin type A, Reloxin, in aesthetics, the FDA has determined not to accept the BLA for filing because it is not sufficiently complete to permit a substantive review.FDA cited reasons were that the application did not address how Medicis would fulfill its responsibilities as the manufacturer of the product and that the application included letters of authorization supporting a separate BLA submitted by Ipsen.The FDA's letter only addressed administrative deficiencies in the application and did not reference any substantive deficiencies. The company continues to believe that its BLA is strong, and it plans to promptly work with the FDA and coordinate its activities with Ipsen to address these administrative issues.While Medicis is uncertain of the impact at this time, the FDA's determination not to accept the company's BLA may result in delays in the FDA's substantive response to the BLA.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.