News

FDA Outlines Process To Speed Up Rare Disease Therapy Approvals

FDA launches Rare Disease Evidence Principles to guide therapy reviews, offering new pathways for approval while raising ...
PharmiWeb3d

FDA Accelerated Approval What’s Changing and Why It Matters for Rare Diseases

Accelerated Approval (AA) pathway, initially established in 1992 during the HIV/AIDS epidemic to provide faster access to ...
Fierce Biotech9d

UPDATE: Analyst questions impact of FDA's rare disease pathway proposal

Makary announced plans for a new rare disease pathway in an April episode of "The Megyn Kelly Show." The proposal follows ...
BioPharma Dive8d

FDA outlines new review pathway for drugs treating ultra-rare diseases

The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect ...
Pharmaceutical Technology on MSN8d

FDA creates new pathway for rare disease drugs, analysts unconvinced

"FDA creates new pathway for rare disease drugs, analysts unconvinced" was originally created and published by Pharmaceutical ...

Gen AI Prescription: Uncovering Hidden Bottlenecks to Accelerate Drug Approvals and Save Lives

Generative AI, once seen as a tool for writers and artists, is now reshaping the high-stakes world of pharma regulation.
PharmTech7d

FDA Initiates Real-Time CRL Publication: What It Means for Drug Developers

The agency says it will now publish complete response letters promptly, offering developers early insight into regulatory ...
BioSpace4d

As Ori Wins Designation, FDA’s Advanced Manufacturing Program Nears Proof Point

Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three ...

Inovio: Back On Track With INO-3107 BLA For RRP Before End Of 2025

INO-3107's rolling BLA progresses after FDA support despite delays. Priority Review may expedite approval by late 2025. Click here to read my analysis.