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.
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive ...
Zydus Lifesciences announces CVS Caremark agreement and FDA priority review for diabetes and Menkes disease treatments.
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 ...
My Capital One Venture X comes with a free Priority Pass membership that gets me access to over 1,700 airport lounges, but ...
The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...
Zydus Lifesciences rose 1.22% to Rs 974.75 after its wholly-owned subsidiary, Sentynl Therapeutics, and Fortress Biotech said that U.S. food and Drug Administration has accepted filing and priority ...
Shares of Verastem Oncology VSTM rallied 40.9% on Tuesday after it announced that the FDA has accepted the new drug ...
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 ...
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.
Going out to eat? See which Marion County restaurants were rated best by inspectors, and which failed the test.
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 ...