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367 stories matching this filter · ← front page

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  • FDA issues warning letters to eight retailers for selling unauthorized tobacco products that mimic candy and other everyday items
    The U.S. Food and Drug Administration announced on May 20, 2026 that it has sent warning letters to eight retailers for offering unauthorized nicotine pouches and dissolvable tobacco products that…
    fda press · 3mo agoRegulatoryNegative↗ source
  • FDA leadership overhaul follows firing of acting CDER director; 20 deaths linked to Amgen’s Tavneos in Japan
    The FDA announced another leadership change, removing acting directors of its two main drug review centers. Tracy Beth Høeg, acting head of the Center for Drug Evaluation and Research (CDER), poste…
    BioPharma Dive · 3mo agoRegulatoryNegative
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  • Republican lawmaker releases FDA analysis of alleged pediatric Covid vaccine deaths
    A Republican congressman has made public an analysis that the FDA commissioned to examine claims of child deaths linked to Covid-19 vaccines. The study was initiated by former senior FDA officials…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Experts debate testing Merck’s Ervebo vaccine for DRC Ebola outbreak amid lack of approved shot
    The Democratic Republic of the Congo confirmed a new Ebola outbreak at the end of May, making it the fourth largest on record. The virus is spreading in a conflict-affected region, complicating con…
    STAT · 3mo agoNegative↗ source
  • Trump administration cuts childhood vaccine schedule, citing personal autonomy
    The opinion argues that the concept of patient autonomy does not apply to childhood vaccination because infants cannot refuse shots; the decision rests with parents. In January, the Department of…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Goodman urges five reforms to restore trust in CDC vaccine advisory committee
    Jesse Goodman, a former director of the FDA's Center for Biologics Evaluation and Research and former chief scientist, wrote an opinion piece calling for major changes to the CDC's Advisory Committ…
    STAT · 3mo agoRegulatoryNegative↗ source
  • WHO declares Ebola outbreak in DRC an international public health emergency
    The World Health Organization announced on Saturday that the Ebola outbreak first identified in the Democratic Republic of the Congo has been declared an international public health emergency. The…
    STAT · 3mo agoNegative↗ source
  • Senator Bill Cassidy loses Louisiana primary, paving way for Trump-backed Julia Letlow
    Senator Bill Cassidy, a leading Republican on health issues, finished third in Louisiana’s Senate primary with about 24.8% of the vote. State treasurer John Fleming received roughly 28%, while Rep.…
    STAT · 3mo agoNeutral↗ source
  • FDA Commissioner Marty Makary Resigns, Prompting Concerns Over Agency Direction
    FDA Commissioner Marty Makary stepped down on Tuesday, leaving the agency without a permanent leader as it already faces turnover in its drug and biologics divisions. Makary had recently appeared…
    STAT · 3mo agoNegative↗ source
  • 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
  • FDA drug division chief Tracy Beth Høeg expected to depart amid leadership shakeup
    Tracy Beth Høeg, who leads the FDA’s Center for Drug Evaluation and Research, is reported to be leaving the agency. Her exit comes shortly after former Commissioner Marty Makary stepped down, sugg…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • 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
  • Supreme Court temporarily blocks ruling, keeping mail-order mifepristone legal
    The U.S. Supreme Court issued an order that temporarily blocks a federal appeals court decision that would have required women to obtain abortion pills in person. The temporary stay preserves the a…
    STAT · 3mo agoRegulatoryPositive↗ 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
  • Valneva to cut up to 15% of workforce as travel slowdown lowers vaccine demand
    Valneva, a French vaccine developer, announced it will lay off between 10% and 15% of its employees. The cuts are linked to a decline in demand for travel vaccines, which the company says is drive…
    Endpoints · 3mo agoLayoffsNegative↗ 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
  • EU drafts Critical Medicines Act to increase local production and curb drug shortages
    The European Union has reached a provisional agreement known as the Critical Medicines Act, aimed at strengthening the supply of essential medicines across member states. The plan focuses on incre…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Immunotherapy trials like PODIUM-303 are reshaping treatment for squamous cell anal cancer, says Dr Parikh
    Dr Aparna R. Parikh, an oncologist at Massachusetts General Hospital and Harvard professor, highlighted the growing feasibility of immunotherapy studies in squamous cell anal carcinoma (SCAC). She…
    onclive · 3mo agoPositive↗ source
  • FDA reopens comment period for BHT and launches post-market chemical safety program
    The U.S. Food and Drug Administration announced two actions as part of its ongoing food chemical safety agenda. The agency will reopen the comment period for the Request for Information on butylat…
    fda press · 3mo agoRegulatoryNeutral↗ source
  • Animal skin disease confirmed in clusters of European men who have sex with men
    European researchers have diagnosed a number of men who have sex with other men with a skin disease that normally infects livestock.
    STAT · 3mo ago↗ source
  • Dr Sznol on the Nuances of Recommending Neoadjuvant Therapy in Metastatic Melanoma
    Mario Sznol, MD, discusses current guidance around the use of neoadjuvant therapy in advanced melanoma.
    onclive · 4mo ago↗ source