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FDA and EMA release collaborative AI framework for drug development

"FDA and EMA release collaborative AI framework for drug development" was originally created and published by Clinical Trials ...
JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
JD Supra

FDA Proposes Sweeping Changes to Accelerate Biosimilar Development

Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...
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An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
PharmTech

The Impact of Patient-Centric Formulations on Service Providers

PharmTech spoke with Dr. Asma Patel, VP Global Commercial and Scientific Consulting–Drug Product, to find out how the growth ...

Ainnocence and Phase Advance Enter Industry-First AI Collab to Reduce Drug Development Timeline and Clinical Trial Risk

The collaboration marks a turning point in AI-driven drug design and trial forecasting, de-risking the drug development ...
WDSU

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

What Galapagos Tortoises Can Teach Us About Drug Development

In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...
WebMD

The FDA Approval Journey for Pegcetacoplan for C3G and IC-MPGN

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...
BioSpace

CDMOs Pin Hopes for Accelerating Uptake at New US Sites on FDA’s PreCheck Program

The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...
STAT

FDA approves first new kind of drug to target gonorrhea in decades

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on ...