A BioSpace analysis of all 80 priority review vouchers that have been handed out across the three FDA programs that offer ...

FDA grants Priority Review to Capricor's deramiocel for Duchenne cardiomyopathy, setting an August 2025 decision date with no ...

The FDA has accepted for Priority Review the BLA for PRGN-2012 for the treatment of adults with recurrent respiratory papillomatosis.

The FDA granted priority review to TLX250-CDx for clear cell renal cell carcinoma imaging, with a PDUFA date of August 27, ...

Capricor Therapeutics' shares rose after its biologics license application for deramiocel to treat a form of muscular dystrophy was given priority review by the Food and Drug Administration. Shares ...

The Food and Drug Administration has accepted Capricor Therapeutics' application seeking approval of its cell therapy deramiocel for muscular dystrophy patients and granted it a priority review. The ...

Chimerix’s lead clinical pipeline candidate is dordaviprone, a first-in-class small molecule treatment designed to selectively target the mitochondrial protease ClpP and dopamine receptor D2 (DRD2).

The Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for deramiocel (CAP-1002) for the treatment ...

Congress did not reauthorize the rare pediatric disease priority review program at the end of 2024. Advocates say the ripple effect is already being felt across biopharma.

Zevra has sold its US Food and Drug Administration (FDA) priority review voucher (PRV) for $150m to an undisclosed party.

In addition to the Priority Review, deramiocel has received Orphan Drug Designation from the FDA and EMA, as well as RMAT and ATMP Designations in the U.S. and Europe, respectively. Furthermore, ...

The FDA has accepted under Priority Review the NDA for lenacapavir for the prevention of HIV as pre-exposure prophylaxis.