FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a ...

Axsome Therapeutics received FDA acceptance and priority review designation for its supplemental new drug application for AXS-05, a treatment for agitation associated with Alzheimer’s disease. The FDA ...

NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today ...

Please provide your email address to receive an email when new articles are posted on . The FDA granted priority review to veligrotug for the treatment of thyroid eye disease, according to a press ...

- Priority Review designation is granted to applications for drugs that, if approved, would be a significant improvement in the safety or effectiveness of treating a serious condition - - Veligrotug ...

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 ...

The FDA has “proactively” granted Johnson & Johnson a coveted speedy review under the Commissioner’s National Priority Voucher pilot (CNPV), the agency said Monday. The voucher was granted to J&J for ...

The FDA's priority review for Opdivo with AVD targets first-line treatment for stage 3 or 4 cHL in patients aged 12 and older. The phase 3 SWOG S1826 study supports the review, focusing on progression ...

The Prescription Drug User Fee Act target date is expected during the second quarter of 2026. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ...

This article originally appeared on OncLive®. The FDA has granted priority review to a new drug application (NDA) seeking the approval of sonrotoclax (BGB-11417; BeOne Medicines) for the treatment of ...