Oncopeptides AB
http://www.oncopeptides.se/
Questions?
Please contact Sales at: (212) 520-2765 or email PharmaNewsSales@informa.com
Latest From Oncopeptides AB
Accelerated Approval Reforms Give US FDA More Power And Flexibility – With Some Gaps
Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.
Oncopeptides Weighing Pepaxto Withdrawal Request
Drama continues for the multiple myeloma treatment as US FDA formally moves to pull accelerated approval. Oncopeptides anticipates making a decision on the request in the first quarter of 2023.
GSK’s Blenrep: 15 Days From Confirmatory Trial Failure To Withdrawal Announcement
The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.
One More Message From Makena: Fighting US FDA Can Pay Off
The US FDA process to force the withdrawal of the pre-term labor drug Makena is in its final stages. The product seems likely to finally leave the market – but may also demonstrate that there is a business to be built in contesting FDA withdrawal proceedings.
Company Information
- Industry
- Pharmaceuticals
-
Biotechnology
- Large Molecule
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Company
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
DCD.EmailPopout.Notice