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

Shares of Capricor Therapeutics (CAPR) closed Tuesday with modest gains and rose more than 3% in extended trading after the ...

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.

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

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for emapalumab-Izsg for use ...

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

Two Foreign Corrupt Practices Act cases—one in Pennsylvania and one in Florida—could get dropped depending on the outcome of the Justice Department’s ongoing review of FCPA enforcement matters.

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

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 ...

Priority Gold makes acquiring precious metals ... This is reflected in the company’s positive reviews across multiple independent platforms. This includes an A+ rating from the Better Business ...

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