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Latest From Imunon, Inc.
US Health And Wellness People News: CHPA, Bayer, Viatris, Qnovia, Powerade
Sanofi consumer health scientific affairs lead moves to CHPA; change in Bayer’s US consumer health marketing helm; Viatris CCO moves from same post at Moderna; Qnovia expands scientific advisory board; and Powerade powers Girls Inc. scholarships, programs.
Endo Slams FDA’s ‘Improper Rationalization’ In Adrenalin Rival’s ‘Unlawful Approval’
Endo’s Par subsidiary insists that long-existing statute for US patent infringement cases should hold off final approval for a supplemental rival to its Adrenalin treatment for anaphylaxis for several years – in contrast to the FDA granting a recent approval to BPI Labs.
BeiGene’s Tevimbra And The End Of The COVID Inspection Era
US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.
Pazdur On Accelerated Approval: FDA Needs To Explain Why It Does Not Always Seek Withdrawal When Trials Fail
Knee-jerk reaction when a confirmatory trial fails is that the drug should be withdrawn, but the agency must undertake a more nuanced evaluation and do a better job explaining it to the public, OCE Director Richard Pazdur says; Pazdur and Project Confirm lead Gautam Mehta spoke with the Pink Sheet about dangling indications, FDORA reforms and the withdrawal process.
Company Information
- Industry
- Biotechnology
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Pharmaceuticals
- Vaccines
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Biotechnology
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
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- Egen, Inc.
- Expression Genetics, Celsion Corporation
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