“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 ...
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
The facility is an extension of the company's USFDA-approved plant that is already supplying to the US, Europe, Japan and ...
A team of scientists has developed a groundbreaking approach using specially designed peptides to improve drug formulations.
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 ...
The Food and Drug Administration issued marketing granted orders to 20 Zyn nicotine pouch products. The announcement on ...
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device ...
Johnson & Johnson (JNJ) said it has submitted an application to the FDA for its therapy candidate TAR-200 for the treatment of a certain type of bladder cancer. Read more here.