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Alongside these changes, a key programme—the priority review voucher programme for paediatric rare diseases—also expired. The programme, which was signed into law in 2012, incentivises the ...

FDA prioritizes review of liso-cel, a groundbreaking CAR T-cell therapy for relapsed marginal zone lymphoma, promising ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower drug costs. Could it work?

In the U.S., a rare disease is defined as one that affects fewer than 200,000 people. This status allows for priority review, fast track status and breakthrough therapy designation.

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema ...

“We are pleased that the FDA has granted Priority Review to our sNDA in R/R mNPM1 AML, a filing which builds on the initial approval of Revuforj for R/R acute leukemia with a KMT2A translocation ...

The Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for sevabertinib (BAY 2927088), an oral tyrosine kinase inhibitor, for the treatment of adult ...

“The FDA’s Priority Review designation acceptance of our sBLA reinforces our confidence in WINREVAIR for a broad range of patients and represents a critical step toward advancing the treatment ...

For " priority reviews," a designation available for drugs offering significant improvements in safety or effectiveness for serious conditions, the performance goal is 6 months.

Nature Reviews Clinical Oncology 15, 731-747. Media Chunhua Lu 86-10-66609879 [email protected] Investors 86-10-66609999 [email protected] ...