Access to the new Alzheimer's drugs is limited by strict eligibility criteria, long wait times, and a lack of infusion ...
The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...
GlobalData on MSN11h
MSD wins FDA priority review for Welireg in rare endocrine cancerThe US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
The FDA has accepted Merck's (MRK) supplemental NDA with priority review for its drug Welireg for the treatment of a rare ...
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
The facility is an extension of the company's USFDA-approved plant that is already supplying to the US, Europe, Japan and ...
The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA ...
Mexico President Claudia Sheinbaum said Tuesday that President Donald Trump’s executive order moving toward designating drug ...
Introduction to Generative AI Generative AI refers to algorithms that can create new content, including text, images, music, ...
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
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