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  • FDA extends safety review of mifepristone into next year, report due by March 2027
    The FDA announced that its ongoing safety evaluation of mifepristone, the primary medication used for medical abortions, will not be completed until next year. The agency expects to finish the saf…
    STAT · 12d agoRegulatoryNeutral↗ source
  • Tailored breast cancer care for older women gains momentum as researchers highlight age-specific tumor differences
    Older women represent a large share of breast cancer diagnoses, with nearly half of cases occurring in patients 65 or older and about one-fifth in those 75 and older. Despite these numbers, clinic…
    STAT · 12d agoPositive↗ source
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  • Everlywell launches AI tool to predict breast cancer risk directly to consumers
    Everlywell, a digital health company known for offering at-home lab tests, has introduced a new artificial intelligence algorithm that evaluates breast cancer risk from medical images. The company…
    STAT · 12d agoPositive↗ source
  • Experts say U.S. must step up to match Europe’s progress in eliminating hepatitis C
    The authors argue that England and several other nations are nearing hepatitis C elimination, while the United States lags behind. They point to recent public attention, such as Pamela Anderson’s…
    STAT · 12d agoNeutral↗ source
  • Smaller biotech firms face uncertainty over U.S. tariff exemptions as new import taxes take effect
    A broad 100% tariff on imported pharmaceuticals introduced at the end of September under the Trump administration has created confusion for many biotech companies. While large drugmakers can use e…
    STAT · 12d agoRegulatoryNegative↗ source
  • FDA unveils transparency roadmap with plans for public NDA/BLA disclosures and inspection report publishing
    The FDA published a transparency roadmap that outlines its FY 2026 achievements and sets out priorities for FY 2027. One key priority is a proposal to require public disclosure of new drug applica…
    raps · 13d agoRegulatoryNeutral↗ source
  • Congressional Bill Aims to End Arbitration in No Surprises Act, Shifting Payments to Median In-Network Rates
    Rep. Frank Pallone introduced the Lower Premiums, Faster Payments Act, which would eliminate the arbitration system used under the No Surprises Act and replace it with a payment model based on medi…
    STAT · 12d agoRegulatoryNeutral↗ source
  • PhRMA sues Trump administration over Medicare price linking pilot program
    The pharmaceutical trade group PhRMA has filed a lawsuit against the Trump administration, challenging a pilot program that would tie Medicare drug prices to the levels seen in peer countries. The…
    STAT · 12d agoRegulatoryNegative↗ source
  • EU Commission urges EMA to fast-track Biotech Act preparations
    The European Commission has issued a statement urging the European Medicines Agency to accelerate work on the upcoming Biotech Act, which aims to streamline regulation of advanced therapies. The C…
    raps · 13d agoRegulatoryNeutral↗ source
  • Trump administration probes nine top universities over alleged J-1 visa misuse for postdocs
    The Trump administration announced an investigation into nine universities for alleged misuse of J-1 visas that support postdoctoral researchers. The schools named include Harvard, Yale, Stanford,…
    STAT · 12d agoRegulatoryNegative↗ source
  • Democrats eye key House committees as midterms approach, opening doors for new health policy influence
    Dozens of Democrats are competing for seats on the House Energy and Commerce and Ways and Means committees as they anticipate winning back control of the chamber. Several incumbents from both part…
    STAT · 12d agoRegulatoryNeutral↗ source
  • All 2026 Nobel laureates in science are men, highlighting ongoing gender gap
    The Nobel committees announced this year’s winners in physiology or medicine, physics and chemistry, and every recipient was male. Women have accounted for roughly 4% of laureates since the awards…
    STAT · 12d agoNegative↗ source
  • AI tool for breast cancer risk moves to direct-to-consumer amid regulatory scrutiny of Utah sandbox
    A startup featured in STAT's Health Tech newsletter is launching its breast cancer risk prediction algorithm directly to patients, bypassing traditional clinical pathways. The direct-to-consumer r…
    STAT · 12d agoNeutral↗ source
  • Democrats compete for new seats on House Energy and Commerce and Ways and Means committees after midterms
    Washington reporters note that the House Energy and Commerce and Ways and Means committees are likely to welcome several new members following the 2026 midterm elections. A combination of a potent…
    STAT · 12d agoNeutral↗ source
  • Mother and daughter seek community for ultra-rare Nicolaides-Baraitser syndrome
    In October 2020 a pediatric geneticist diagnosed an 11‑year‑old girl, Maya, with Nicolaides‑Baraitser syndrome, a condition documented in only 61 cases in the scientific literature. The doctor war…
    STAT · 12d agoNeutral↗ source
  • Gardeners Basics Recalls Waltham 29 Broccoli Sprouting Seeds Due to Possible Salmonella Contamination
    October 8, 2026, Gardeners Basics of Spanish Fork, Utah, is recalling one-pound bags of broccoli sprouting seeds because they may be contaminated with Salmonella, an organism which can cause seriou…
    fda recalls · 12d ago↗ source
  • Recon: FDA identifies four deaths in Newron schizophrenia drug trials; Dutch court blocks subcutaneous Keytruda in eight Europea...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 13d ago↗ source
  • Optogenetics therapy restores light sensitivity in half of retinitis pigmentosa patients in early trial
    A small clinical study examined an optogenetics‑based approach for treating retinitis pigmentosa, a genetic disorder that progressively destroys retinal light‑sensing cells and often leads to legal…
    STAT · 13d agoPositive readoutPositive↗ source
  • 2026 Nobel Chemistry Prize honors research on chiral molecules with implications for drug development
    Henri B. Kagan, 95, and Kenso Soai, 76, received the 2026 Nobel Prize in chemistry for their work on asymmetric organic synthesis. Their research uncovered how certain reactions can act as their o…
    STAT · 13d agoPositive↗ source
  • EMA to revise pharmacogenomics guideline as MHRA adopts AI framework for medical devices
    The European Medicines Agency’s Committee for Medicinal Products for Human Use is preparing a major revision of its 2018 guideline on good pharmacogenomic practices. Regulators say the rapid advan…
    raps · 14d agoRegulatoryNeutral↗ source
  • Trump administration proposes $70,000 fee for OPT program, raising concerns for biotech talent pipeline
    The Department of Homeland Security announced a proposal to charge $70,000 for the Optional Practical Training (OPT) program, which allows international students on F-1 visas to work in the United…
    STAT · 13d agoRegulatoryNegative↗ source
  • PhRMA sues Trump administration over Medicare GLOBE price pilot
    PhRMA filed a lawsuit in the U.S. District Court for the District of Columbia challenging the Trump administration's GLOBE pilot that would tie Medicare Part B drug prices to those in peer nations.…
    STAT · 13d agoRegulatoryNegative↗ source
  • Dutch court blocks Merck's subcutaneous Keytruda in several European markets
    A Dutch court has ruled that Merck infringed a patent covering a subcutaneous formulation of its cancer drug Keytruda. The decision requires the company to stop manufacturing and marketing that ver…
    STAT · 13d agoRegulatoryNegative↗ source
  • Forbion secures $2.6 billion in its biggest European venture fund to date
    Forbion, a leading European venture capital firm, announced it has closed a $2.6 billion fund, the largest it has raised and among the biggest recent funds in the region. The new capital will be d…
    STAT · 13d agoDealPositive↗ source
  • DOJ expands fraud enforcement to include drug and device makers under FD&C Act
    The Justice Department's National Fraud Enforcement Division released a new directive aimed at combating white-collar fraud, highlighting violations of the Federal Food, Drug, and Cosmetic Act. In…
    STAT · 13d agoRegulatoryNegative↗ source