Sentynl took over the therapy’s development and commercialisation from Fortress Biotech's subsidiary Cyprium Therapeutics.

The NDA is supported by data from the open-label, single-center phase 1/2 90-CH-0149 trial and the open-label, single-arm phase 3 09-CH-0059 study.

The U.S. Food and Drug Administration (FDA) has accepted Sentynl Therapeutics Inc.’s New Drug Application (NDA) for CUTX-101 ...

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...

Fortress Biotech (FBIO) and its majority-owned subsidiary, Cyprium Therapeutics announced the acceptance for review of the New Drug Application ...

The US Food and Drug Administration (FDA) has accepted for priority review the new drug application (NDA) for avutometinib to be used in combination with defactinib for the treatment of adults with ...

A new drug application has been submitted to the FDA for dordaviprone to treat recurrent H3K27M-mutant diffuse glioma.

The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...

A new drug application seeking the accelerated approval of dordaviprone forrecurrent for H3K27M-mutant diffuse glioma ...

An NDA has been accepted by the FDA for the combination of avutometinib and defactinib in KRAS-mutated recurrent low-grade ...

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under Priority Review for avutometinib, in combination with defactinib, for the treatment of adults with ...

Union Public Service Commission i.e. UPSC has extended the registration date for NDA and CDS I 2025 recruitment. Candidates ...