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  • FDA places clinical hold on Aardvark’s Prader-Willi drug amid heart safety concerns
    The Food and Drug Administration has issued a clinical hold on Aardvark Therapeutics' experimental treatment ARD-101 for Prader-Willi Syndrome after safety signals were identified. The hold follow…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • 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
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fda recalls69
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fda press38
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Infectious Disease444
  • 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
  • Expert outlines sequencing strategies for relapsed/refractory multiple myeloma amid rise of T-cell redirecting therapies
    Dr. Diana Cirstea, a specialist in multiple myeloma, explained how treatment sequencing is evolving for patients with relapsed or refractory disease. She highlighted that the growing availability o…
    onclive · 3mo agoNeutral↗ source
  • Pembrolizumab with BCG shows 92% 6-month complete response in very high-risk T1 bladder cancer
    A clinical study evaluated the combination of pembrolizumab and bacillus Calmette-Guérin (BCG) in patients with very high-risk T1 non-muscle invasive bladder cancer who had not previously received…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Detalimogene Voraplasmid Achieves 54% Complete Response in BCG-Unresponsive Bladder Cancer
    A clinical study of detalimogene voraplasmid reported a 54% complete response rate in patients with heavily pretreated, BCG‑unresponsive non‑muscle‑invasive bladder cancer that also had carcinoma i…
    onclive · 3mo agoPositive readoutPositive↗ 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
  • Prevention and personalized skin care highlighted as future direction for melanoma oncodermatology
    Dr. Beth McLellan, a dermatologist, emphasizes that preventing radiation-induced skin damage is becoming a central focus in melanoma care. She also points out the need for equitable access to scal…
    onclive · 3mo agoPositive↗ 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 · 3mo 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
  • OncLive poll highlights top GI cancer abstracts and interest areas for ASCO 2026
    OncLive conducted a poll among its audience to gauge which gastrointestinal cancer abstracts are expected to generate the most interest at the upcoming ASCO Annual Meeting. The poll results identi…
    onclive · 3mo agoNeutral↗ 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
  • Dr Croll reviews study linking tumor size changes on scans to pathological outcomes after neoadjuvant therapy in kidney cancer
    Dr Benjamin Croll, MD, presented findings from a recent investigation into the relationship between radiographic size changes and pathological response in renal cell carcinoma patients receiving ne…
    onclive · 3mo agoNeutral↗ source
  • Dr Garzotto reviews efficacy of aglatimagene besadenovec with valacyclovir and radiation in localized prostate cancer
    Dr Mark Garzotto presented data on a novel therapeutic approach for localized prostate cancer that combines the gene therapy agent aglatimagene besadenovec with the antiviral drug valacyclovir and…
    onclive · 3mo agoNeutral↗ 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
  • GU experts poll top abstract topics for ASCO 2026 meeting
    A poll of genitourinary oncology specialists was conducted to gauge interest in upcoming ASCO 2026 abstracts. Participants used OncLive’s social media platform to nominate the abstracts they expec…
    onclive · 3mo agoNeutral↗ source
  • Roswell Park Researchers Join 2026 World Indigenous Cancer Conference
    Roswell Park Comprehensive Cancer Center staff took part in the 2026 World Indigenous Cancer Conference, a global gathering focused on cancer issues affecting Indigenous peoples. The conference br…
    onclive · 3mo agoPositive↗ source