STAT Reports Lindsay Clancy Case Highlights Fragmented U.S. Care And Postpartum Coordination Gaps
Daniel Cho
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Regulatory & Policy
FDA actions, approvals, policy shifts and compliance: how the rules change timelines and probability.
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FDA Opens TEMPO Pilot To Four Generative AI Devices, Creating A Limited Early-Market Path
Sophia Reynolds
ARPA-H Commits Up To $125M For GIVE RNA Manufacturing Network, Backing Distributed Personalized Production
Michael Torres
FDA Raises Foreign Trial Scrutiny, Tightening Standards As China Research Expands
Dr. Alex Morgan
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SEC And FDA Sign Three-Year Information-Sharing Pact, Tightening Biopharma Insider Trading Scrutiny
Dr. Priya Nandakumar
NIH’s Plan to Bar International Researchers from Key Career Pathways Sparks Debate in Biomedical Community
Jonathan Blake
Sanofi Shortages Myozyme And Nexviazyme After FDA Warning At Waterford Plant
Sophia Reynolds
Amgen Loses New U.K. Tavneos Starts, As FDA Hearing Fight Continues
Michael Torres
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Sep 2, 2026SEC And FDA Sign Three-Year Information-Sharing Pact, Tightening Biopharma Insider Trading Scrutiny
The pact does not create entirely new SEC powers, but it gives both agencies a more formal mechanism to exchange non-public information and route requests through designated points of contact. For biopharma companies, the practical implication is a tighter link between what is said to investors and what the FDA may know about clinical trials, approvals, and other regulated events.
Dr. Priya Nandakumar
Sep 2, 2026UniQure Files AMT-130 For FDA And U.K. Review, Reopening A Huntington’s Gene Therapy Path After FDA Reversal
The applications put AMT-130 on track to become the first genetic treatment for Huntington’s disease if regulators agree that three-year Phase 1/2 data can support accelerated approval. The bigger signal is regulatory: the case tests how far the FDA will go in accepting external controls and small-population gene therapy data after a public dispute inside the agency earlier this year.
Emily CarterSep 2, 2026Amgen Loses New U.K. Tavneos Starts, As FDA Hearing Fight Continues
The Medicines and Healthcare products Regulatory Agency said its move followed a review of all available evidence and concerns about the integrity and reliability of data from the study supporting the medicine’s authorization. Amgen said it disagrees with the U.K. decision and is building its defense of Tavneos with an independent analysis and patient testimonials.
Michael Torres
Aug 29, 2026Juul Gets FDA Clearance For Juul2 With Optional Age Verification, Reopening Its U.S. Device Pipeline
The FDA said the determination is not an approval or endorsement, and that people who do not smoke should not use Juul or other e-cigarettes. The policy signal is that the agency is still willing to authorize nicotine products when the record supports adult cigarette harm reduction, even as youth-use controls remain central to the commercial case.
Dr. Priya Nandakumar
Aug 28, 2026Lilly Wins Mounjaro Cardiovascular Risk Approval, Matching Novo In A Key GLP-1 Market
Lilly supported the filing with the SURPASS-CVOT trial, which enrolled 13,000 participants across 30 countries over more than four and a half years. Mounjaro showed non-inferiority to Trulicity, with an 8% lower rate of cardiovascular death, heart attack or stroke in the study.
Dr. Priya NandakumarRFK Jr. Faces New Scrutiny Over Samoa Letters, Complicating Vaccine Policy Credibility
The documents, obtained by The Associated Press and The Guardian, include a letter in which Kennedy proposed studying Samoa's MMR vaccines after the deaths of two children who had received them. The Department of Health and Human Services said the Samoa visit was unrelated to vaccines and called claims that Kennedy lied to Congress false and defamatory.
Dr. Alex Morgan
Aug 27, 2026Hospitals Plot Push To Rework $1 Trillion In Medicaid Cuts, Even As Trump Law Stands
Hospital systems are remaking operations after the passage of a law that will cut nearly $1 trillion in Medicaid funding over the next decade, while lobbyists in Washington search for ways to mitigate the damage. The opening, according to people familiar with the effort, is less about a clean repeal now than about carving out narrower fixes, favorable rule changes and other federal payment support while the politics of the cuts harden.
Emily Carter
Aug 27, 2026FDA Review Extension Keeps Capricor’s Deramiocel Filing Alive, As Moderna And Merck Add Phase 3 Vaccine Momentum
The article spans several companies, but the common thread is policy and review risk shaping biotech valuations and strategy. Capricor’s extension, Moderna’s stock move after cancer vaccine data, and the naming of a commissioner nominee each show how quickly sentiment can shift when the FDA timetable or leadership picture changes.
Michael Torres
Aug 27, 2026Vitruvias Recalls 3,655 Thyroid Tablet Units And Ceases Operations, Handing Products To H2-Pharma
The recall affects tablets distributed across the U.S. last year and was made with the FDA’s knowledge. The event combines a product quality problem with the disappearance of the company behind it, creating immediate continuity questions for a niche generic medicine.
Jonathan Blake
Aug 26, 2026FDA Considers Two Deputy Commissioner Roles, Extending Its Leadership Reset Into AI And Drugs
According to CNBC, the FDA is considering new deputy commissioner positions that would report to the commissioner. The potential change comes as President Donald Trump has nominated Heidi Overton for the top job and as industry watchers look for steadier leadership across the agency’s review functions.
Emily Carter
Aug 26, 2026Teva Faces Turkish Antitrust Probe Over Patent Tactics And Rival Drug Statements
Turkey’s Competition Board said Teva may have used practices aimed at making it more difficult for competitors to enter the market. The regulator did not name a specific drug, while a Teva spokesperson linked the matter to the earlier European Commission probe that resulted in a $503 million fine now under appeal.
Daniel ChoPennsylvania Reports Two Measles Deaths, As U.S. Cases Reach 2,777 This Year
State officials said the two people who died were unvaccinated residents of Lancaster County, and Pennsylvania has now counted nearly 400 measles cases this year. The deaths add pressure to a vaccination debate that has intensified as national coverage rates fall below the level typically needed to prevent outbreaks.
Emily CarterOther beats
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