Seeking regulatory approval for a new therapy involving the FDA and Grifols.

The entities involved

• FDA →
  • A company has entered into a non-clinical evaluation agreement with NIAID, partnering with AFRRI on protocol design that meets FDA Animal Rule criteria.13:17
  • FDA approved a GSK drug and authorized a Roche blood test for eligibility, amidst estimates of 1.7M chronic HBV patients in the US.12:54
• Grifols →

  Spanish pharmaceutical company

  • Altimmune, Inc. and Grifols are being compared as healthcare companies.Sun 19:26
  • Grifols, Canadian Blood Services, and Health Canada are working on a framework for sustainable plasma collection.Sat 11:49

Related events

• A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Jun 7
• FDA approval expands patient access to therapies for ACCORD.Jul 10
• The FDA requested additional clinical data from Unicycive Therapeutics.Jun 29
• FDA provided guidance for HCW Biologics' IND application.Oct 9
• Research advances have led to the approval of new therapies by the FDA.Oct 15