February 2, 2022

Montgomery Business: County Life Sciences Companies Receive Significant FDA Approvals or Authorizations to Start the New Year

The Montgomery County Economic Development Corporation (MCEDC) can point to many examples of why the world-impacting drug and medical science developments being advanced here make Montgomery the “Immunology Capital Next to the Nation’s Capital.” Several companies supported by MCEDC have recently taken significant strides.

The Food and Drug Administration (FDA), located in White Oak, in 2021 approved more than 50 novel drugs. Recently it gave four companies either based in Montgomery County or with major operations in the County approvals for new drugs, emergency use authorization or Investigational New Drug allowances.

County-based businesses with significant advancements since the start of the year include:
  • Cartesian Therapeutics: The Gaithersburg-based company received its fifth FDA Investigational New Drug allowance for a Phase 1/2a multicenter clinical study evaluating Descartes-25 in patients with multiple myeloma.
  • Immunocore: Approval for the treatment of unresectable or metastatic uveal melanoma was given to the United-Kingdom based company that has a major operation in Rockville.
  • Maxim Biomedical: Emergency use authorization was given to the Rockville-based company for its at-home COVID-19 antigen test, ClearDetect, which does not require an external reader or dropper bottles.
  • REGENXBIO: The Rockville-based company earned FDA clearance to initiate a first in-human study of its gene therapy for a rare form of muscular dystrophy.
More information on companies operating in Montgomery County that are making an impact on health around the world can be found on the MCEDC website at https://thinkmoco.com/.