FDA Approves First New Non-Opiod Painkiller in Decades
Journavx is designed to eliminate the risks of addiction and overdose associated with medications like Vicodin and OxyContin.
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MSD wins FDA priority review for Welireg in rare endocrine cancer
The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
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Jubilant Ingrevia commissions new facility in Gujarat to manufacture nutraceuticals and dietary-active ingredients
The facility is an extension of the company's USFDA-approved plant that is already supplying to the US, Europe, Japan and ...
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FDA approves drug application for Lupin’s heart failure therapy
The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...
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Mexico defends sovereignty as US seeks to label cartels as terrorists
Mexico President Claudia Sheinbaum said Tuesday that President Donald Trump’s executive order moving toward designating drug ...
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Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
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Generative AI: Revolutionizing Industries
Introduction to Generative AI Generative AI refers to algorithms that can create new content, including text, images, music, ...
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FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
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The pharma stocks leading the race for new drugs
While the resulting product, Pluvicto, has already been approved by the US Food and Drug Administration (FDA), the new study, if successful ... the FDA accepted it and Daiichi Sankyo’s joint ...
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FDA beats EMA to most approved new drugs in 2024
to the most approved drugs with a new active substance in 2024. On 15 January, the two agencies released respective lists of medicines approved last year. The FDA approved 50 novel drugs that ...