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FDA prevails over EMA in 2025 novel drug approvals

This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...
Healio

Q&A: FDA update to biosimilar approval process may reduce time, cost of development

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
Targeted Oncology

For a Second Time, FDA Denies Approval of Tab-Cel in EBV+ PTLD

In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...
Oncology Nurse Advisor

FDA Accelerated Approval for Oncology Drugs Leads to Improved Patient Survival

In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.

Exclusive: US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...

NRx Pharmaceuticals (Nasdaq:NRXP) Announces 70,000 Patient Data on Real World Use of Ketamine for Treatment of Suicidal Depression to be Submitted to the FDA i…

NRX-100 (preservative-free ketamine) has been granted Fast Track Designation by FDA for treatment of suicidal ideation in ...

Fast-tracked drug approvals pose safety risks, study shows

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...
HDBuzz

UniQure Secures Type A Meeting with FDA: What This Means for AMT-130

6 min read | UniQure secured a Type A FDA meeting, a high-priority discussion for urgent issues. Within 30 days, both sides will discuss what kind of data package might support the advancement of ...