[E-Daily Reporter kyoungeun kim ]HLB Life Science(067630)announced on the 10th that its U.S. subsidiary, Elevar Therapeutics, received a Complete Response Letter (CRL) from the FDA on the 9th (local time) regarding its first-line treatment for liver cancer (a combination of riboceranib and camrelizumab).
The FDA notified Elevar that it had identified deficiencies at the facility following a CGMP (Current Good Manufacturing Practice) inspection.
The issues raised by the FDA are as follows: △ A re-inspection of the facility by the FDA may be necessary for the facility to achieve CGMP compliance; △ The findings identified during the inspection may not be directly related to Elevar Therapeutics’ application.
Eleva Therapeutics stated that it plans to promptly address the above issues and proceed with a re-approval application to the FDA.
The FDA notified Elevar that it had identified deficiencies at the facility following a CGMP (Current Good Manufacturing Practice) inspection.
The issues raised by the FDA are as follows: △ A re-inspection of the facility by the FDA may be necessary for the facility to achieve CGMP compliance; △ The findings identified during the inspection may not be directly related to Elevar Therapeutics’ application.
Eleva Therapeutics stated that it plans to promptly address the above issues and proceed with a re-approval application to the FDA.
