Hosted on MSN18h
FDA accepts Sentynl’s Menkes disease therapy NDA for priority review
Sentynl took over the therapy’s development and commercialisation from Fortress Biotech's subsidiary Cyprium Therapeutics.
Targeted Oncology16h
FDA Grants Priority Review to Sunvozertinib in EGFR+ NSCLC
The FDA granted priority review to sunvozertinib for the treatment of advanced NSCLC with EGFR exon 20 mutations, based on ...
Senate Republicans prepare blitzkrieg on Biden regulations
Senate Republicans, waiting for their House counterparts to figure out their strategy on border security and tax reform, are ...
Monthly Prescribing Reference1d
SubQ Copper Histidinate Formulation Gets Priority Review for Menkes Disease
The NDA is supported by data from the open-label, single-center phase 1/2 90-CH-0149 trial and the open-label, single-arm phase 3 09-CH-0059 study.
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive ...
Cancer Therapy Advisor2d
Avutometinib Gets Priority Review for Low-Grade Serous Ovarian Cancer
The US Food and Drug Administration (FDA) has accepted for priority review the new drug application (NDA) for avutometinib to be used in combination with defactinib for the treatment of adults with ...
Cure Today3d
FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...
Monthly Prescribing Reference5d
Avutometinib Plus Defactinib Get Priority Review for Rare Type of Ovarian Cancer
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under Priority Review for avutometinib, in combination with defactinib, for the treatment of adults with ...
I got a free Priority Pass membership with my credit card. It's not as useful as I'd hoped, but it's a pretty good value.
My Capital One Venture X comes with a free Priority Pass membership that gets me access to over 1,700 airport lounges, but ...
Verastem Shares Soar on FDA Priority Review of Cancer Treatment
Shares of Verastem surged after the company's new cancer treatment got priority review from regulators. The stock was up 46% at $5.37 on Tuesday. Shares are still down 35% since the start of the year.
Business Insider8d
Verastem announces FDA acceptance and Priority Review of NDA for Avutometinib
The NDA, which was completed in October 2024, has been granted Priority Review with a Prescription Drug User Fee Act – PDUFA – action date of June 30, 2025. In addition, the FDA has stated ...