Back To The Drawing Board: Which Drugs Received Complete Response Letters From The FDA In July?

India, Sept. 1 -- The biotechnology sector is a high-risk investment arena, and investing in these companies requires considerable patience. Drug developers can spend years - even decades - and billions of dollars bringing a new therapy to market.

While some drugs sail through the FDA approval process, others face a long and often complex regulatory journey, with some ultimately receiving a Complete Response Letter (CRL). Here are the companies that received CRLs from the FDA in July.

Ascelia Pharma

Ascelia Pharma AB (publ)(028300.KQ,ACE.ST) was issued a Complete Response Letter by the FDA on July 2, 2026, for its New Drug Application for Orviglance.

Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent in developm...