FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals.

Chlorine Dioxide, Raw Camel Milk: The FDA No Longer Warns Against These and Other Ineffective Autism Treatments

The FDA has taken down a webpage warning about therapies and products making “false claims” of treating autism. It’s part of a series of actions the agency has taken under Secretary Robert F. Kennedy ...
Engadget

OpenAI releases Prism, a Claude Code-like app for scientific research

OpenAI is releasing a new app called Prism today, and it hopes it does for science what coding agents like Claude Code and its own Codex platform have done for programming. Prism builds on Crixet, a ...
Morningstar

Professor Sarfaraz Niazi's Scientific Framework Adopted as FDA Modernizes Clinical Trial Evaluation Through Bayesian Methods

WASHINGTON, Jan. 20, 2026 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has issued new draft guidance modernizing statistical methodologies used in clinical trials, formally recognizing ...
MedPage Today

FDA Flags Boston Scientific Device Tied to 3 Deaths, Scores of Injuries

The FDA sent an early safety alert warning clinicians of deployment failures with certain Boston Scientific AXIOS Stent and Electrocautery Enhanced Delivery Systems that have been linked to three ...
BioWorld

FDA approves Boston Scientific's Farapoint

Boston Scientific Corp.'s Farapoint, its latest pulsed field ablation catheter, received U.S. FDA approval for use as an adjunctive device when treating persistent atrial fibrillation that requires ...
Reuters

Illumina unveils dataset to speed up AI-powered drug discovery

Jan 13 (Reuters) - Gene sequencing company Illumina (ILMN.O), opens new tab on Tuesday introduced a dataset that maps genetic changes to help accelerate drug ...
Becker's Hospital Review

FDA loosens data rules for select medical device submissions

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...
InfoWorld

PythoC: A new way to generate C code from Python

PythoC lets you use Python as a C code generator, but with more features and flexibility than Cython provides. Here’s a first look at the new C code generator for Python. Python and C share more than ...
Nasdaq

Cereno Scientific Receives FDA Clearance to Initiate Global Phase IIb Trial of CS1 in Pulmonary Arterial Hypertension (PAH)

GOTHENBURG, Sweden, Dec. 8, 2025 /PRNewswire/ -- Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare ...