A Prescription Drug User Fee Act target date of August 19, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) ...

Findings showed nipocalimab plus standard of care (SOC) improved MG-ADL score from baseline by 4.70 points compared with 3.25 points with placebo plus SOC over weeks 22, 23, and 24. The Food and Drug ...

Kumar is the chief executive and co-founder of BridgeBio Pharma. Thousands of children’s lives have been saved by a cost-free government initiative that expired last December. Congress needs to renew ...

A research letter published in JAMA Internal Medicine this week finds that class III medical devices that receive expedited reviews are more likely to be recalled, and after spending less time on the ...

The FDA granted Welireg a priority review after it showed promising outcomes for patients with pretreated advanced renal cell carcinoma. The Food and Drug Administration (FDA) granted a priority ...

The FDA awarded two national priority review vouchers through its Commissioner’s National Priority Voucher pilot program on Dec. 19, bringing the total granted to 18. The latest vouchers were issued ...

Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for IMAAVY® ...

The FDA granted a priority review for a new supplemental Biologics License Application to Keytruda plus concurrent chemoradiotherapy for patients with locally advanced cervical cancer. The Food and ...