The FDA believes that data on MRD and complete response can expedite new drug delivery compared with long-term survival ...

Single Phase 2/3 Adaptive Study Design - - Clinically Relevant, Objective Composite Endpoint - SAN DIEGO, CA / ACCESS Newswire / January 21, 2026 /Revelation Biosciences, Inc. (NASDAQ:REVB) (the ...

Stringent food safety regulations will inspire innovation in machinery standards while encouraging dairy manufacturers to invest in high-quality processing equipment. However, staffing and skill ...

Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support ...

Cortigent is a leading developer of brain interface devices based on precision neurostimulation technology The company’s new ...

BDX wins FDA 510(k) clearance for the EnCor EnCompass breast biopsy system, set for an early 2026 launch to boost flexibility and patient care.

Amendment reduces and simplifies royalty structure on Teverelix® from ~4% to 2% while preserving global rights and IP control ...

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

In the draft guidance, the agency discusses how sponsors can leverage MRD and complete response rates as near-term efficacy measures and speed new therapies to market.

Macrolides are an important class of antibiotics that includes drugs such as azithromycin and erythromycin, which are widely ...

Objective To help to clarify whether long term use of proton pump inhibitors is associated with an increased risk of gastric ...