Pharmaceutical Commerce

FDA Shifts Toward Single Trial Requirement for New Drug Approvals

A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate ...
The Munich Eye

FDA Revises Drug Approval Process to Require Only One Clinical Trial

Munich news, health insurance, technology, jobs and other topics for expatriates. The Eye Newspapers covers daily news and offers services for foreigners.
Zacks Investment Research on MSN

Novocure gains FDA approval for Optune Pax to treat pancreatic cancer

Novocure NVCR recently announced the FDA approval for its portable therapeutic device, Optune Pax, for treating adult ...
Managed Healthcare Executive

FDA issues draft guidance on MRD and complete response as primary endpoints for accelerated multiple myeloma drug approvals

FDA proposes MRD-negative and complete response endpoints to fast-track multiple myeloma drug approvals, pushing deeper molecular results over ORR.
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Taysha outlines accelerated BLA timeline for TSHA-102 with FDA Breakthrough Therapy designation and full global rights

CEO Sean Nolan stated, “The recent regulatory clarity and progress we've achieved, which was enabled by the strength of our REVEAL Part A data set, rigorous data evaluation methodology, and our ...
BioSpace

Disc’s Regulatory Comeback Plan for Rejected Drug Relies on Old FDA Leadership

Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the ...
Seeking Alpha

Taysha outlines accelerated BLA timeline for TSHA-102 with FDA Breakthrough Therapy designation and full global rights

Management reiterated plans to initiate the REVEAL pivotal trial for TSHA-102, with the first patient dosing scheduled for the current quarter and additional enrollment expected across multiple sites.