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663 stories matching this filter · ← front page

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  • Ebola surge in DRC and hantavirus cases on cruise ship highlight gaps in global outbreak preparedness
    Recent reports from the Democratic Republic of Congo describe an Ebola outbreak in Ituri province with 246 suspected cases and 65 deaths, and early testing points to a non‑Zaire ebolavirus strain.…
    STAT · 3mo agoNegative↗ source
  • FDA drug center acting director Tracy Beth Høeg resigns amid leadership vacuum
    Tracy Beth Høeg, the acting director of the FDA’s Center for Drug Evaluation and Research, is leaving the agency, according to three sources familiar with the matter. Her departure follows the res…
    STAT · 3mo agoRegulatoryNegative↗ source
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fda recalls67
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Infectious Disease444
  • Ebola outbreak confirmed in Congo's Ituri province, 65 deaths among 246 suspected cases
    Africa CDC announced a new Ebola outbreak in the remote Ituri province of the Democratic Republic of Congo, noting 246 suspected infections and 65 fatalities. Most of the reported cases and deaths…
    STAT · 3mo agoNegative↗ source
  • U.S. officials urge Germany to raise drug prices in trade talks
    U.S. Trade Representative Jamieson Greer and senior health adviser Chris Klomp met with German Ambassador Jens Hanefeld at a breakfast briefing to press Germany to increase the price it pays for pr…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Aardvark to unblind rare disease trial after FDA places full clinical hold; Alumis issues verdict on Acelyrin asset
    Aardvark's rare disease candidate is under a full clinical hold by the FDA, which has paused all dosing and data collection. The company says it intends to unblind the trial data despite the hold,…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Nonprofits launch Zillow-style marketplace to match abandoned gene and cell therapies with new developers
    Two nonprofit groups announced the launch of an online marketplace designed to give abandoned cell and gene therapy projects a chance for redevelopment. The platform, unveiled at the American Socie…
    Endpoints · 3mo agoPositive↗ source
  • Regenxbio reports key gene therapy results, moves toward FDA accelerated clearance for Duchenne
    Regenxbio said its experimental gene therapy RGX-202 met the primary endpoint in a pivotal Duchenne muscular dystrophy trial, positioning the company to file for accelerated FDA clearance. In the…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • Regenxbio reports successful Duchenne gene therapy trial, clearing path to FDA filing
    Regenxbio announced that its experimental gene therapy for Duchenne muscular dystrophy met its primary endpoints in a recent clinical trial, producing sufficient levels of a truncated muscle protei…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Phase III trial shows tebentafusp doubles five-year survival in untreated metastatic uveal melanoma
    A Phase III study of tebentafusp in patients with previously untreated metastatic uveal melanoma reported that five-year overall survival was roughly twice that of the control group. The trial als…
    onclive · 3mo agoPositive readoutPositive↗ source
  • BeOne Medicines receives accelerated FDA approval for sonrotoclax in mantle cell lymphoma
    BeOne Medicines announced that the U.S. Food and Drug Administration granted accelerated approval to its BCL2 inhibitor sonrotoclax for treatment of mantle cell lymphoma. The approval is based on…
    Endpoints · 3mo agoApprovalPositive↗ source
  • FDA commissioner Marty Makary exits, acting head Kyle Diamantas named as podcast discusses impact and Senate health race
    The Readout Loud podcast episode focused on health politics, featuring a discussion of FDA commissioner Marty Makary's departure. Hosts examined why Makary is leaving, which of his policies might…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Regenxbio reports positive Duchenne gene therapy trial results, targets FDA approval by 2027
    Regenxbio announced that its gene therapy for Duchenne muscular dystrophy achieved the required endpoints in a pivotal clinical trial. The data met the study's predefined criteria, which the compa…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • MRI Features That Suggest Diffuse Midline Glioma Highlighted in Expert Discussion
    In a recent educational segment, Dr. Chong introduced the clinical scenario where patients with suspected brain tumors are first evaluated with imaging before tissue sampling. He then asked Dr. Sh…
    onclive · 3mo agoNeutral↗ source
  • FDA leadership gap deepens uncertainty for biotech as acting officials take charge
    Marty Makary's resignation as FDA commissioner has left the agency without a permanent head. Kyle Diamantas is serving as the temporary leader, while three senior drug-review positions are filled b…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Trump administration seeks new FDA commissioner to restore trust, prioritize food policy and accelerate drug approvals
    The Trump administration is moving quickly to name a successor to FDA commissioner Marty Makary, who resigned. Officials say the search will take several weeks and they are looking for a leader wh…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Abeona shifts from eye gene therapy to solid tumor T‑cell programs as AstraZeneca’s rare disease drug clears Phase 3
    Abeona Therapeutics announced it is ending its eye‑focused gene‑therapy projects and will redirect resources toward developing T‑cell based treatments for solid tumors. The company says the pivot…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Gene therapy viral vectors implicated in a child’s tumor, raising safety concerns
    A recent STAT+ report highlights a case where viral vectors used in gene therapy were found to be associated with a tumor in a young boy. The article notes that investigators have identified a poss…
    STAT · 3mo agoNegative↗ source
  • Safety-boosting drug may weaken gene therapy efficacy in Dravet syndrome trial
    Encoded Therapeutics studied a drug meant to improve the safety of gene therapy in children with Dravet syndrome, a severe genetic epilepsy. In the trial of 21 participants, most received steroids…
    STAT · 3mo agoNegative readoutNegative↗ source
  • Doctors link infant's brain tumor to gene therapy virus in rare case
    Doctors treated 13-month-old Adam with an experimental gene therapy after his stem cell transplant failed, and the boy subsequently reached developmental milestones such as learning sign language a…
    STAT · 3mo agoNeutral↗ source
  • Hantavirus outbreak on cruise ship tests US biocontainment capacity, highlights response gaps
    Passengers from the MV Hondius cruise ship were placed in a Nebraska quarantine facility after several were diagnosed with Andes hantavirus, an emerging infectious disease. The virus, while deadly…
    STAT · 3mo agoNeutral↗ source
  • Hospitals restricting doctors' social media posts may worsen health misinformation, says physician
    Adam Goodcoff, chief medical officer at HealthCentral, began creating health content online while in medical school, using short videos to explain procedures and counter myths, such as the depth of…
    STAT · 3mo agoNegative↗ source
  • FDA chief Marty Makary resigns, ending turbulent tenure
    FDA chief Marty Makary has resigned, ending a tenure described as turbulent with leadership upheaval, mass layoffs, political pressure and public disputes with drugmakers. President Trump announce…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Supreme Court grants three-day extension on ruling over abortion drug mifepristone
    The U.S. Supreme Court announced it will take an additional three days before issuing a decision in the case concerning the abortion medication mifepristone. The case, Louisiana v. FDA, reached th…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Pain drug research gains momentum a year after Vertex launch as new startups revive sodium channel targets
    A year after Vertex introduced its breakthrough pain medication, the field of pain drug development is at a pivotal crossroads. Analysts note that renewed scientific focus and investor interest are…
    BioPharma Dive · 3mo agoPositive↗ source
  • Former FDA Commissioner Marty Makary resigns under pressure, critics call his tenure the weakest in 25 years
    Marty Makary stepped down as FDA commissioner on Tuesday after mounting pressure, ending a tenure that many observers described as the weakest in the agency’s recent history. Critics said he lacke…
    STAT · 3mo agoRegulatoryNegative↗ source