Complete Response Letters

The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.

During a virtual appearance at a CERSI meeting two days after announcing retirement plans, the CDER director also said she wished agency reviews of unapproved drugs could be published.

Tanvex has seen its application for a trastuzumab biosimilar knocked back by the US Food and Drug Administration, receiving a complete response letter over the filing.

After sharing multiple updates to the regulatory status of its ketamine formulation, PharmaTher received a complete response letter from the FDA, which required minor information and clarifications from the company.

The company will file a new drug application with the US FDA by the end of the year for tradipitant in a different indication, motion sickness.

The company will file a new drug application with the US FDA by the end of the year for tradipitant in a different indication, motion sickness.

Historically, announcements from biotech companies have triggered stock price fluctuations as investors misinterpret the details. However, two recent instances suggest this pattern might be shifting.

Sponsor of psychedelic PTSD treatment will try rarely successful formal dispute resolution process after receiving a complete response letter. 

US FDA would need to approve 44 novel agents by year-end to match 2023’s big total, but only 40 candidates are known to have user fee goals in the second half of 2024.

The drug maker said the US FDA issued a complete response letter for insulin icodec that included requests related to manufacturing process and the type 1 diabetes indication.