Regeneron Pharmaceuticals, Inc.
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Latest From Regeneron Pharmaceuticals, Inc.
Fighting Accelerated Approval Withdrawal Hinders Other Sponsors' Applications, FDA’s Pazdur Says
Resource-intensive withdrawal process means FDA reviewers are not able to work on other drugs, Oncology Center of Excellence Director Richard Pazdur says, citing the ‘arduous’ withdrawal of Pepaxto. Pazdur also says no one should be surprised that the FDA has begun issuing complete response letters when confirmatory studies are not sufficiently advanced.
BMS’s Abecma Shakes Up Myeloma With Earlier-Line Approval From FDA
The US FDA approved Abecma for multiple myeloma after two prior lines of therapy, while the agency was also expected to imminently decide on earlier-line approval for J&J/Legend’s Carvykti.
Keeping Track: Cardio-Renal Drugs At Heart Of US FDA’s March Approval Binge
Seven novel agents approved in March include one accelerated approval, two rare pediatric disease priority review vouchers, two breakthrough therapy designations and one regenerative medicine advance therapy designation.
Quick Listen: Scrip's Five Must-Know Things
In this week's podcast edition of Five Must-Know Things: Merck & Co progresses cardiovascular strategy; Novo purchase builds heart failure presence; CRL setbacks for Regeneron; ITF faces challenging Duchenne field; and AbbVie needs to freshen up.
Company Information
- Industry
- Pharmaceuticals
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Biotechnology
- Drug Discovery Tools
- Gene Therapy, Cell Therapy
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Large Molecule
- Antibodies
- Other Names / Subsidiaries
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- Checkmate Pharmaceuticals, Inc.
- Regeneron Genetics Center LLC (RGC)
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