financetom
Business
financetom
/
Business
/
SpringWorks' Neurofibromatosis Therapy Application Receives FDA Priority Review
News World Market Environment Technology Personal Finance Politics Retail Business Economy Cryptocurrency Forex Stocks Market Commodities
SpringWorks' Neurofibromatosis Therapy Application Receives FDA Priority Review
Aug 28, 2024 4:51 AM

07:18 AM EDT, 08/28/2024 (MT Newswires) -- SpringWorks Therapeutics ( SWTX ) said on Wednesday that the U.S. Food and Drug Administration had accepted a new drug application for its experimental therapy, mirdametinib, to treat adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas.

The company said the application was granted Priority Review and that a decision was expected by Feb. 28, 2025.

In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.

SpringWorks also said that the European Medicines Agency had validated the marketing authorization application for mirdametinib.

Comments
Welcome to financetom comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
Related Articles >
Brera Regains Compliance With Nasdaq Listing Requirement
Brera Regains Compliance With Nasdaq Listing Requirement
Apr 1, 2025
05:06 PM EDT, 04/01/2025 (MT Newswires) -- Brera ( BREA ) said late Tuesday it received a Nasdaq notice stating that the company has regained compliance with its annual meeting requirement for continued listing. The company held its annual meeting on March 28, resolving a previous non-compliance notice issued on Feb. 3, Brera ( BREA ) said. ...
Jamf Holding Completes Acquisition of Identity Automation
Jamf Holding Completes Acquisition of Identity Automation
Apr 1, 2025
05:06 PM EDT, 04/01/2025 (MT Newswires) -- Jamf Holding ( JAMF ) completed the acquisition of Identity Automation, which makes software for industries such as education and health care to manage user identities, streamline access to digital resources and enhance security. Jamf ( JAMF ) announced the purchase on March 3 for $215 million in cash. Identity Automation's platform dynamically...
Equity Commonwealth Board Approves Final Liquidation Distribution; Shares to Delist on April 21
Equity Commonwealth Board Approves Final Liquidation Distribution; Shares to Delist on April 21
Apr 1, 2025
05:13 PM EDT, 04/01/2025 (MT Newswires) -- Equity Commonwealth ( EQC ) said late Tuesday its board authorized the final cash liquidating distribution of $1.60 per share, payable on April 22 to holders as of April 11. The authorization brings the aggregate cash liquidating distributions to $20.60 per share, including the $19 per share paid in December. The company said...
Soccer-Elanga haunts former club to fire Forest to victory over Man United
Soccer-Elanga haunts former club to fire Forest to victory over Man United
Apr 1, 2025
NOTTINGHAM, England, April 1 (Reuters) - Anthony Elanga's breakaway goal against his former club earned high-flying Nottingham Forest a 1-0 victory over Manchester United ( MANU ) in the Premier League on Tuesday. The Swede left Old Trafford to make way for big-money signing Antony two years ago and played like he had a point to prove at the City...
Copyright 2023-2026 - www.financetom.com All Rights Reserved