Grace submitted a new drug application (NDA) for GTx-104 and filed financial reports with the SEC.

The entities involved

• Grace →

  Nothing else this week.

• FDA →
  • Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
  • A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56
• SEC →

  Slovak company

  • DHS, DOJ, and SEC formed a joint initiative to establish a Trade Fraud Task Force, setting standards for compliance.Mon 17:57
  • The Fidelis Partnership is incorporating in Bermuda and filing for an initial public offering on the NYSE, with principal offices in London and a main office in Dublin.Mon 17:12

Related events

• The FDA recommended advancement for a new drug application submitted by a company.Jun 8
• BioXcel Therapeutics received FDA approval for its drug and announced results from New Haven.Jun 7
• Kowa's New Drug Application (NDA) for drug K-911 was accepted by the FDA for review.Aug 27
• The FDA is currently reviewing new drug applications for market entry.Jun 22
• Biocon's subsidiary received FDA approval for a drug in the United States on August 18, 2026.Aug 18