JD Supra

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design

Biological products, or biologics, are large, complex molecules produced in living systems such as therapeutic proteins, antibodies, and gene- or cell-based therapies. Under the Public Health Service ...

Revelation Biosciences Reaches Agreement with FDA on Gemini Approval Pathway for AKI

SAN DIEGO, CA / ACCESS Newswire / January 21, 2026 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company that is focused on rebalancing ...
Frontiers

Embodied Approaches to Intervention and Research Design in Clinical Psychology: Integrating Body, Context, and Measurement

Clinical psychology has long recognized that psychological distress and therapeutic change involve more than cognitive processes alone. Emotion regulation, ...
Seeking Alpha

Aridis Receives Agreement from the FDA on a Single Confirmatory Phase 3 Study of AR-301 and the Clinical Study Design

“We are particularly gratified to reach concurrence with the FDA on the overall study design, endpoints, and patient populations,” said Aridis CEO Vu Truong. “This provides a clear clinical and ...
Nasdaq

Izotropic Updates Timelines for Clinical Study and Fabrication of Initial Izoview Units

Izotropic announced today it has completed a comprehensive review of its R&D strategy to yield a differentiated offering for the Company's priority markets, while positioning the business for ...
Morningstar

Nona Biosciences Collaboration Partner Pfizer Announces Presentation of Phase 1 Clinical Study Design on MesoC2, an MSLN-Targeting ADC, at the 2025 ASCO Annual Meeting

"We are excited to see Pfizer advancing MesoC2 into clinical development rapidly, highlighting the potential of Nona's Harbour Mice® and integrated ADC platforms to deliver innovative cancer therapies ...
Nature

How AI is being used to accelerate clinical trials

For decades, computing power followed Moore’s law, advancing at a predictable pace. The number of components on an integrated circuit doubled roughly every two years. In 2012, researchers coined the ...
JD Supra

A Bevy of Recent FDA Updates on Innovation in Clinical Trial Design

Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and ...
Business Wire

Azitra, Inc. Announces Positive Preclinical Data of ATR-12 and Clinical Design in Netherton Syndrome Presented at the ASGCT Annual Meeting

BRANFORD, Conn.--(BUSINESS WIRE)--Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced ...
CNN

A 1747 study found the treatment for scurvy. A man accused of ‘quackery’ may have inspired it

Sign up for CNN’s Wonder Theory science newsletter. Explore the universe with news on fascinating discoveries, scientific advancements and more. The first ...
Seeking Alpha

Aridis Receives Agreement from the European Medicines Agency (EMA) on the Clinical Study Design and a Single Confirmatory Phase 3 Study of AR-301

LOS GATOS, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (ARDS) today announced positive feedback from the European Medicines Agency (EMA) on the Company’s proposed single ...