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CMS announces voluntary “GENEROUS” Medicaid most-favored-nation drug pricing model, planned to launch in 2026

14 November 2025

News

FDA announces “plausible mechanism” approval pathway for certain personalized therapies, with few details

13 November 2025

Insights and Analysis

2026 Medicare Physician Fee Schedule Final Rule adopts some but not all Average Sales Price proposals and revised Medicare Inflation Rebate regulations

05 November 2025

Insights and Analysis

How to Negotiate Cell & Gene Therapy Contracts with German Treatment Centers

04 November 2025

News

FDA rethinks need for comparative efficacy studies for certain biosimilars

31 October 2025

News

The Belgian Federal Agency for Medicines and Health Products accelerates clinical trial evaluations to boost access to innovative treatments

15 October 2025

News

FDA Device Guidance Agenda: What to Watch in 2026

15 October 2025

News

(Update) FDA releasing CRLs for unapproved drugs and biologics, including applications not previously publicly disclosed or acknowledged

09 October 2025

News

CMS Issues Final Guidance on IPAY 2028 Drug Price Negotiation Program, 2026-28 MFP Effectuation

06 October 2025

Insights and Analysis

CTGT/ATMP clinical trials surge in China, as first stem cell therapy product is conditionally authorized

30 September 2025

News

Cell & gene therapy clinical trials, development promoted in three new FDA guidance documents

25 September 2025

News

Japan’s conditional approval pathway offers regenerative medicines earlier market access

25 September 2025

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