Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Celsion Corporation

https://celsion.com/

Latest From Celsion Corporation

Yo-Yo Approvals? Maybe Accelerated Approval Isn’t Fixed After All

Oncopeptides’ reversal on Pepaxto may or may not prove to be the right decision – but it underscores the inherent limits to US FDA’s efforts to police ‘dangling’ accelerated approvals.

Review Pathway Cancer

Oncopeptides Rescinds Pepaxto Voluntary Withdrawal, Which Could Set Up Battle With US FDA

After more review of clinical trial data, the myeloma drug’s sponsor wants to talk to the FDA again, but Oncopeptides execs said they cannot disclose the scientific details that led to the decision.

Clinical Trials Drug Approval Standards

‘Dangling’ Cancer Indications In US: New Year Brings New Withdrawals Of Accelerated Approvals

Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.

Clinical Trials Review Pathway

Olympus Medical Follows The Patient Pathway In New Strategic Plan

Having divested non-medical imaging a year ago, Olympus Corp is putting its foot to the floor in refocusing on its medical portfolio. It has set global ambitions of strengthening its coverage of unmet needs and of playing a major role in reshaping health care delivery.

Commercial Medical Device
See All

Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Biotechnology
    • Gene Therapy, Cell Therapy
    • Large Molecule
  • Other Names / Subsidiaries
    • Egen, Inc.
    • Expression Genetics
UsernamePublicRestriction

Register