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2,325 stories matching this filter · ← front page

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  • Biotech execs push for Rick Pazdur as FDA chief while Takeda announces 4,500 layoffs
    Hundreds of biotechnology executives, investors and patient advocates have signed a petition urging President Trump to nominate Rick Pazdur as the next FDA commissioner. Pazdur, a longtime FDA vet…
    BioPharma Dive · 3mo agoLayoffsNeutral↗ 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
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  • 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
  • Supreme Court blocks lower court ruling, keeps mail-order access to abortion pill mifepristone
    The Supreme Court issued an indefinite stay that preserves mail-order access to the abortion medication mifepristone. The order maintains the ability for providers to prescribe the drug through pha…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ 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
  • UK election may reshape drug pricing while US urges Germany to pay more for medicines
    The upcoming political contest in the United Kingdom is being watched for its possible effects on how medicines are priced domestically. Analysts suggest that a change in government could lead to n…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Supreme Court temporarily restores telehealth access to mifepristone amid ongoing legal fight
    The Supreme Court on Thursday reversed a 5th Circuit order and allowed mifepristone to be prescribed and mailed through telehealth for the time being. The reversal follows a lawsuit brought by Lou…
    STAT · 3mo agoRegulatoryNeutral↗ 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
  • 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
  • DOJ alleges Yale and UCLA med schools discriminate against white and Asian applicants
    The U.S. Justice Department sent a letter to Yale School of Medicine on Thursday accusing it of illegal discrimination against applicants who are not Black or Hispanic. The allegation follows a si…
    STAT · 3mo agoRegulatoryNegative↗ source
  • PSA Blood Test Found to Lower Prostate Cancer Deaths, Review Shows
    A new Cochrane review concludes that prostate-specific antigen (PSA) screening is likely to reduce deaths caused by prostate cancer. The analysis combined data from six trials involving roughly 80…
    STAT · 4mo agoPositive↗ source
  • Takeda to Pay $13.6 Million to Resolve DOJ Claims of Doctor Kickbacks for Antidepressant Trintellix
    Takeda Pharmaceuticals has agreed to pay $13.6 million to settle federal allegations that it provided illegal kickbacks to physicians to encourage prescriptions of its antidepressant, Trintellix. T…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Older adults warn that changing pill colors and shapes cause dangerous confusion
    Barbara Wolf, a 73‑year‑old from Birmingham, Alabama, takes six medications each day and relies on the color, shape and size of each pill to keep her regimen straight. She recently received a refi…
    STAT · 3mo agoNegative↗ source
  • US pushes Germany on drug pricing while FDA faces turmoil and biotech trials advance, says Pharmalittle roundup
    The newsletter notes that U.S. lawmakers are intensifying pressure on Germany to lower the prices of pharmaceuticals, a move that could reshape cross-border pricing negotiations. At the same time,…
    STAT · 3mo agoNeutral↗ source
  • Alcohol’s deadly toll is overlooked as a public-health crisis, STAT explores why
    STAT’s weekly video series highlighted that alcohol kills more Americans than any other drug, yet it is rarely framed as a public‑health emergency. The contrast between its mortality impact and pub…
    STAT · 3mo agoNeutral↗ source
  • Basking Biosciences appoints former Pulmocide chief medical officer Lance Berman
    Basking Biosciences announced the addition of Lance Berman as its new chief medical officer. The appointment was highlighted in a recent industry column that tracks personnel changes. Berman comes…
    STAT · 3mo agoNeutral↗ source
  • Remembering Craig Venter: The Complex Legacy Behind the Human Genome Race
    Former NIH archivist Zachary Utz reflects on the recent death of Craig Venter, a prominent figure in genomics known for challenging conventional scientific approaches. Venter’s private company Cel…
    STAT · 3mo agoNeutral↗ source
  • BeOne secures FDA approval for lymphoma therapy
    BeOne received FDA approval for its lymphoma therapy, a notable achievement in a crowded therapeutic area. The agency’s review concluded that the treatment meets safety and efficacy standards, pla…
    STAT · 4mo agoApprovalPositive↗ 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 · 4mo 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 · 4mo agoPositive readoutPositive↗ source
  • Supreme Court blocks restrictions, keeps mifepristone available through pharmacies and mail
    Supreme Court on Thursday issued an order that maintains women's ability to obtain the abortion medication mifepristone without requiring an in-person doctor visit. The decision overturns a lower-…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Create Medicines secures $122M Series B to advance in vivo CAR-T therapies
    Create Medicines, a Cambridge biotech, announced a $122 million Series B financing to expand its in vivo CAR-T cell therapy platform targeting cancer and autoimmune diseases. The round was co-led…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Biogen advances tau-targeting Alzheimer drug to Phase 3 despite mixed Phase 2 data
    Biogen reported results from a Phase 2 trial of its tau-targeting Alzheimer’s candidate diranersen (BIIB080). The study measured tau levels in cerebrospinal fluid and brain tissue of patients with…
    STAT · 4mo agoPositive readoutPositive↗ 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 · 4mo agoRegulatoryNeutral↗ source
  • Biogen reports mixed results in mid‑stage trial of tau‑targeting Alzheimer’s therapy
    Biogen disclosed data from a Phase 2 study of its experimental Alzheimer’s drug that targets the tau protein. The trial showed a combination of positive and negative signals, with some measures ind…
    STAT · 4mo agoNegative readoutNeutral↗ source