Browsing Tag
Food and Drug Administration
31 posts
FDA shocks Neurotech with rejection of orphan drug status for life-changing PANDAS/PANS treatment
Neurotech International Limited is facing an uphill battle after the United States Food and Drug Administration (FDA) declined…
October 4, 2024
LifeVantage stock soars on game-changing GLP-1 study results – here’s what you need to know
Shares of LifeVantage Corporation have jumped 8.2% after the company announced encouraging results from a study on its…
September 10, 2024
This new FDA-approved insulin pump just sent Modular Medical’s stock soaring 27%—Find out why!
Shares of Modular Medical, Inc. soared by 27% to reach $2.49, surpassing its previous 52-week high of $2.22,…
September 5, 2024
FDA approves Janssen’s TECVAYLI for multiple myeloma treatment
The Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, announced the US Food and Drug Administration’s approval…
October 27, 2022
Ayala Pharmaceuticals AL102 gets FDA fast track status in desmoid tumors
Ayala Pharmaceuticals has been granted fast track designation for its oral gamma-secretase inhibitor AL102 by the US Food…
September 29, 2022
Lupin launches generic Suprep Bowel Prep Kit in the US after FDA approval
Lupin launches FDA-approved generic Suprep Bowel Prep Kit in the US, entering a $202M market and expanding its gastrointestinal portfolio.
September 20, 2022
FDA approves Opdivo and Cabometyx combo for advanced kidney cancer treatment
The U.S. Food and Drug Administration (FDA) has officially approved the combination of Bristol Myers Squibb’s Opdivo (nivolumab)…
January 26, 2021
BRILINTA FDA approval: A major step in reducing stroke risks in acute ischemic stroke and high-risk TIA patients
AstraZeneca has secured U.S. Food and Drug Administration (FDA) approval for BRILINTA (ticagrelor), expanding its use to reduce…
November 8, 2020
Masimo gets FDA clearance for Centroid patient monitoring sensor
Masimo, a US medical device company, has received clearance from the US Food and Drug Administration (FDA) for…
June 28, 2020
PADCEV, KEYTRUDA combination for advanced bladder cancer gets FDA breakthrough therapy status
PADCEV, KEYTRUDA combination : Astellas Pharma and Seattle Genetics said that the combination of PADCEV (enfortumab vedotin-ejfv) and…
February 20, 2020