The FDA plans to drop its requirement for two studies to approve new drugs, aiming to speed up the availability of medicines.
In an interview, Jackson Peter Kim, MD, clinical assistant professor in the Division of Nephrology at Stanford Health Care, ...
With this decision, Optune Pax becomes the first new FDA-approved treatment for locally advanced pancreatic cancer in decades ...
Pharmaceutical Technology on MSN
PTC pulls Translarna NDA after unfavourable FDA feedback
This verdict could spell the end for Translarna’s decades-long and tumultuous US DMD development journey.
A partnership comprising TransCode Therapeutics and Quantum Leap Healthcare Collaborative has submitted an investigational ...
Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...
NEW YORK — Bio-Techne said on Monday that its Ella benchtop immunoassay platform has received CE-IVD marking, permitting its sale in the EU.
By Padmanabhan Ananthan Feb 2 (Reuters) - Aquestive Therapeutics said on Monday the U.S. FDA has declined to approve its oral drug for severe allergic reactions due to packaging issues, marking a ...
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