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Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray
“We are pleased the FDA has accepted our NDA for Bumetanide Nasal Spray,” said Benjamin Esque, CEO of Corstasis Therapeutics Inc. “This milestone brings us closer to providing a simple, easy-to-use ...
The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
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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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New approach uses peptides to enhance anti-tumor drug formulations
A team of scientists has developed a groundbreaking approach using specially designed peptides to improve drug formulations.
US FDA drops web pages on improving clinical trial diversity
The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
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 ...
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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 ...