Ultragenyx Wins FDA Accelerated Approval for GENGLYCOS in GSDIa

GENGLYCOS is the first gene therapy approval, and fifth FDA approval overall, for the company Approval provides a long-awaited first-ever option to redu...

August 21, 2026 | Friday | News
Syneos Health Advances Enterprise AI Ecosystem for Clinical Development

Syneos Health®, a leading fully integrated biopharmaceutical solutions organization, announced the continued advancement of its AI ecosystem – ...

August 20, 2026 | Thursday | Opinion
FDA Seeks Input on Regulatory Framework for GenAI-Enabled Medical Devices

The U.S. Food and Drug Administration issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enable...

August 20, 2026 | Thursday | News
Cellution Biologics Completes Acquisition of SimpliDerm Business From Elutia

Cellution Biologics Inc. (“Cellution Biologics” or the “Company”), a biologics company focused on developing, manufacturing and c...

August 20, 2026 | Thursday | News
Trinity Biotech’s Trinovium Partners with Echelon on AI Data Center Cooling

- Collaboration with leading hyperscale data center company will support Trinovium's technical and commercial readiness through development of cooli...

August 19, 2026 | Wednesday | News
Enigma Biomedical USA Receives FDA Approval for TAUKLARIFY Tau PET Imaging Agent

-Enigma Biomedical USA (EB USA) today announced the U.S. Food and Drug Administration (FDA) approval of TAUKLARIFY™ (florquinitau F 18 injection, a...

August 18, 2026 | Tuesday | News
Nanochon Receives Panama Approval to Begin First-in-Human Chondrograft Knee Study

Nanochon, a medical device company developing Chondrograft, a novel patented implant for the treatment of articular cartilage defects of the knee, announ...

August 17, 2026 | Monday | News
Veloxis Pharmaceuticals to Pay $46 Million to Resolve Envarsus XR Fraud Case

In a major healthcare fraud enforcement action, Veloxis Pharmaceuticals will pay over million and accept a stringent deferred prosecution agreement ...

August 17, 2026 | Monday | News
Aizen Therapeutics Enters Multi-Program Collaboration to Develop AI-Designed Oral Peptides

Aizen Therapeutics, an AI-native biotechnology company focused on building oral biologics, announced a multi-program collaboration with a San Diego-based...

August 17, 2026 | Monday | News
Cycle Pharmaceuticals Partners With Forma to Manufacture CAVHANZA in U.S.

Cycle Pharmaceuticals (“Cycle”), a global pharmaceutical company focused on rare diseases, and Forma Life Sciences, Inc. (“Forma”...

August 14, 2026 | Friday | News
NurExone Signs MOU With Made Scientific for U.S. GMP Exosome Manufacturing Partnership

NurExone Biologic Inc. ("NurExone" or the "Company") (TSXV: NRX, OTCQB: NRXBF, FSE: J90), a biotechnology company developing exosome-based regenerative t...

August 14, 2026 | Friday | News
Belite Bio Wins FDA Priority Review for Tinlarebant in Stargardt Disease

Prescription Drug User Fee Act target action date is February 12, 2027 If approved, tinlarebant would be the first-ever approved treatment for Stargar...

August 13, 2026 | Thursday | News
Leica Biosystems Secures FDA Clearances for AI-Assisted Pathology Quality Control and Digital Scanners

Leica Biosystems, a Danaher company and a global leader in end-to-end anatomic and digital pathology solutions, announced multiple U.S. Food and Drug Adm...

August 13, 2026 | Thursday | News
Revvity Launches SuperFlex Prenatal Screening System for Smaller Labs

Revvity’s new maternal and fetal biochemistry testing platform Designed for accessibility, simplicity, and flexibility Purpose-built for small...

August 13, 2026 | Thursday | News

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