BioSpace News Archive

Reducing the dose of medicine. Splitting the pills. Health care and medication. White medical pill broken into three pieces on blue background.

Regulatory

GSK again pulls application for leucovorin, touted by FDA as potential autism treatment

GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing to its potential to treat cerebral folate deficiency with “autistic features.”

April 10, 2026

·

2 min read

·

Tristan Manalac

3D illustration for Polygon hand touches mirrored data in cyberspace, big data processing, analytics concept

Opinion

Opinion: For AI to have impact, the industry must align on data

In the future of AI-driven biopharma, reusable data is the most undervalued asset.

April 10, 2026

·

5 min read

·

Julie Frearson

Finding Talent. Big Hands with Magnifying Glass Recruiting People. vector

Regulatory

FDA probes abortion pill anew after court keeps mail access alive

A Louisiana court on April 7 asked the FDA to complete its internal review of mifepristone’s safety and gave the agency six months to provide the court with an update on the investigation.

April 10, 2026

·

2 min read

·

Tristan Manalac

Creative medicine health sport concept photo of man person made of pills drugs running for doping.

Editorial

With oral obesity race underway, all eyes are on Lilly’s Foundayo launch

Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has come from behind the Danish rival in the weight loss space before, last time it clearly had the better drug.

April 10, 2026

·

3 min read

·

Jef Akst

A person and a group of people are separated by a yellow line. Establishing contact. Distrust. Quarantine. Distance with strangers. Barrier to understanding, difficult integration. Rejection, refusal.

Complete response letters

Replimune’s advanced melanoma drug rebuffed by FDA for second time

The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.

April 10, 2026

·

2 min read

·

Heather McKenzie

Press Releases

Decoy Therapeutics Builds Momentum with Accelerating Execution, Entering a Highly Catalytic Phase with a Clearly Defined Path to Clinical Development of its Antiviral Pipeline

April 10, 2026

·

7 min read

Press Releases

Global Alzheimer’s Platform Foundation Announces Strategic Collaboration and Partnership with Siemens Healthineers for the Transformative Bio-Hermes-002 Study