A company submitted a request for Rare Pediatric Disease Designation to the FDA.

The entities involved

• 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
• Company →

  Direct Mail Division of FSSI

  • A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Mon 13:17
  • A partnership with BARDA has accelerated the development of SCY-247 for the company.Mon 13:17
• Precision BioSciences →

  American gene editing company

  • Precision BioSciences and Incepta Pharmaceuticals were noted as belonging to a specified industry in August 2025.Sat 20:39

Related events

• FDA approval enables commercial opportunity involving CBRE Group.Sep 17
• FDA approval is the goal for product candidates from Daré Bioscience, Inc.Jun 7
• The FDA requested additional clinical data from Unicycive Therapeutics.Jun 29
• Future sales of a product are contingent upon obtaining the necessary FDA registration and labeling, while the state simultaneously announces actions to remove regulatory barriers.Sep 21
• The FDA recommended advancement for a new drug application submitted by a company.Jun 8