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Recon: Germany’s Merck in talks to acquire SpringWorks; Judge orders FDA, CDC to restore deleted portions websites
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
Trump administration ordered to restore removed CDC and FDA websites (Reuters)
Halt on Trump administration’s cuts to NIH research payments expanded nationwide (STAT)
Key GOP senators push back against NIH funding cuts (STAT)
How RFK Jr. could revive a dormant task force to scrutinize vaccine safety (STAT)
CVS Health's turnaround efforts in focus amid record-high medical costs (Reuters)
Insurer Humana forecasts 2025 profit below estimates, expects drop in membership (Reuters)
FDA Appears to Be Granting Zombie Rare Pediatric Disease Designations Waiting for the Rare Pediatric Disease Priority Review Voucher Program to be Revived (FDA Law Blog)
In Focus: International
Germany's Merck in advanced talks to acquire US biotech firm SpringWorks (Reuters)
Number of confirmed Ebola cases in Uganda rises to nine (Reuters)
Updated EU Guidance Reinforces How Notified Bodies Should Use Existing Evidence (MedTech Insight)
Balancing Competitiveness and Sustainability In EU Regulations, What’s Next For Pharma (Pink Sheet)
Depemokimab & Tzield Among 10 New EU Filings (Pink Sheet)
Pharma & Biotech
How the ‘amyloid mafia’ took over Alzheimer’s research (STAT)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.