JD Supra

AI Drug Development: FDA Releases Draft Guidance

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and ...
BioSpace

REGENXBIO, Novartis, Dyne near FDA submissions in muscular dystrophies

Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major ...
Business Wire

Advicenne Reaches a Significant Milestone With the US FDA in the Development of ADV7103 in Cystinuria

PARIS--(BUSINESS WIRE)--Regulatory News: Advicenne (Euronext Growth Paris ALDVI – FR0013296746) a specialty pharmaceutical company dedicated to the development and commercialization of innovative ...

Poolbeg Pharma gets positive FDA feedback for development pathway of lead cancer therapy asset

Poolbeg Pharma PLC (AIM:POLB, OTC:POLBF, FRA:POLBF), the clinical-stage biopharmaceutical company, has received positive ...
RAPS

AI in drug development: FDA draft guidance addresses product lifecycle, risk

The US Food and Drug Administration (FDA) has released a new draft guidance on the use of artificial intelligence (AI) that produces data or information that supports regulatory decision-making in ...
JD Supra

FDA seeks input on real-time clinical trials pilot, AI use in studies

The U.S. Food and Drug Administration (FDA) announced a “real-time clinical trials” (RTCT) pilot program to permit agency reviewers to review ...
STAT

FDA’s new guidance on AI in drug development centers the risk introduced by the technology

Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag of clinical AI, digital health at the FDA, and the boom in direct-to-consumer ...
RAPS

FDA issues draft guidance on mpox drug development

In a much-anticipated draft guidance issued on Thursday, the US Food and Drug Administration (FDA) said that unlike smallpox therapeutics, treatments for mpox cannot be developed under the Animal Rule ...
Healio

FDA aims to accelerate biosimilar development as way to reduce drug costs

Please provide your email address to receive an email when new articles are posted on . The FDA issued draft guidance that would streamline testing of biosimilars. A separate plan would eliminate ...
Medscape

FDA Aims to Streamline Biosimilar Drug Development

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

US FDA approves AbbVie's rare blood cancer drug

(Corrects to clarify the total number of patients in the study in paragraph 10) May 27 (Reuters) - The U.S. Food and Drug ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.