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  • FDA misses self-imposed deadline on electric shock device ban, prompting disability advocates' outcry
    The Food and Drug Administration did not issue a decision by the end of May as it had set for itself on whether to prohibit electrical shock devices used on people with intellectual disabilities an…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Hospitals grapple with patient requests for unvaccinated donor blood
    Some patients are now asking hospitals to provide blood that comes only from donors who have not received any COVID-19 vaccine, creating a new set of ethical and logistical questions. The demand r…
    STAT · 3mo agoNeutral↗ source
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  • New No Surprises Act arbitration rule may increase provider disputes, critics say
    The administration released a final rule on Thursday that tweaks the No Surprises Act arbitration process. The changes are meant to improve communication between insurers and providers and give Med…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Residency dismissals disproportionately affect Black and Latino trainees despite medical school diversification
    Medical schools have made notable progress in diversifying their student bodies, with enrollment of Black and Latino students rising over the past decade through pipeline programs, scholarships, an…
    STAT · 3mo agoNegative↗ source
  • Revolution Medicines' Daraxonrasib Doubles Survival in Pancreatic Cancer Trial, Study Shows
    Results from a late-stage trial of the experimental pill daraxonrasib were presented at the American Society of Clinical Oncology meeting. The data showed that patients receiving the drug lived alm…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Revolution Medicines' daraxonrasib nearly doubles survival in pancreatic cancer trial
    Data presented at the American Society of Clinical Oncology meeting showed that Revolution Medicines' experimental drug daraxonrasib significantly extended survival for patients with metastatic pan…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Ivonescimab cuts death risk by 34% in Chinese trial for squamous NSCLC
    Data presented at the American Society of Clinical Oncology showed that ivonescimab, a bispecific antibody combining two established cancer drugs, lowered the risk of death by 34% compared with sta…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Phase 3 trial shows pre- and post-surgery hormone therapy improves outcomes for high-risk prostate cancer
    A phase 3 study called PROTEUS evaluated high‑risk, early‑stage prostate cancer patients who were scheduled for surgery. The trial compared a regimen that gave two hormone therapies before and afte…
    STAT · 3mo agoPositive readoutPositive↗ source
  • RevMed earns standing ovation at ASCO for pancreatic cancer data while Akeso faces caution
    At the American Society of Clinical Oncology meeting, RevMed captured audience attention with data on its pancreatic cancer therapy, earning a rare standing ovation. In contrast, presentations fro…
    STAT · 3mo agoNeutral↗ source
  • Ultra-low dose nivolumab shows survival benefit for head and neck cancer patients in India
    Researchers presented data at the American Society of Clinical Oncology meeting showing that an ultra‑low dose of the PD‑1 inhibitor nivolumab, given with chemotherapy, extended survival for patien…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Ivonescimab cuts death risk by one-third in Chinese lung cancer trial, adds four-month survival
    A trial in China evaluated ivonescimab combined with chemotherapy in patients newly diagnosed with advanced non-small cell lung cancer. The study was presented at the American Society of Clinical O…
    BioPharma Dive · 3mo agoPositive readoutNeutral↗ source
  • Revolution Medicines begins shipping experimental pancreatic cancer drug daraxonrasib under FDA early access program
    Revolution Medicines announced that it has started sending its experimental pancreatic cancer therapy, daraxonrasib, to doctors and patients through an FDA‑authorized early access program. The comp…
    STAT · 3mo agoRegulatoryPositive↗ source
  • BioNTech and Pfizer present bispecific cancer data at ASCO, FDA chief notes optimism
    At the American Society of Clinical Oncology meeting, BioNTech and Pfizer highlighted early results from bispecific antibody programs aimed at lung cancer. The companies described the data as promi…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Former FDA oncology chief says political turmoil opens chance to reshape agency amid rising Chinese competition
    Rick Pazdur, who led oncology reviews at the FDA, told a STAT audience at the American Society of Clinical Oncology meeting that recent political appointments have caused significant disruption at…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Trump administration abandons Biden Ebola response plan, opting for new strategy
    The Biden administration completed a multi-hundred-page set of guidelines in early 2025 outlining how federal agencies should handle future disease threats, including protocols for Ebola outbreaks…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Bristol Myers reports Phase 3 data showing mezigdomide extends survival in relapsed multiple myeloma
    Bristol Myers Squibb presented Phase 3 results for its experimental multiple myeloma drug mezigdomide at the American Society of Clinical Oncology meeting. The study evaluated mezigdomide combined…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Pfizer partners with China's Innovent Biologics on $10 billion cancer drug collaboration
    Pfizer announced a major partnership with Chinese biotech Innovent Biologics, valued at over $10 billion, to develop cancer therapies. The agreement covers up to 12 antibody-based candidates, incl…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Merck touts promising ADC sacituzumab tirumotecan as potential cornerstone therapy at ASCO
    Merck highlighted a new antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), licensed from Chinese biotech Kelun-Biotech, at the ASCO meeting. The company said early clinical data have give…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Positive data from Bristol Myers in multiple myeloma and Pfizer in lung cancer unveiled at ASCO
    At the American Society of Clinical Oncology (ASCO) meeting, Bristol Myers Squibb presented early-stage results that showed a favorable response in a multiple myeloma trial. The data suggest the in…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Trump administration proposes overhaul of federal grant rules, sparking researcher concerns
    The White House released a more than 400-page proposal that would rewrite the core regulation governing all federal grants. The administration says the changes are meant to curb waste and increase…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Replimune to file third FDA application for RP1 cancer therapy after productive talks
    Replimune announced it will submit a third marketing application for its experimental cancer therapy RP1, following what the company described as productive discussions with the Food and Drug Admin…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • Allogene CEO David Chang to step down as Agios drug misses mid-stage trial results
    Allogene announced that its chief executive, co‑founder David Chang, will leave the role after an eight‑year tenure. Chang, who previously worked at Kite Pharma, will remain on the company’s board…
    BioPharma Dive · 3mo agoNegative readoutNeutral↗ source
  • Former FDA official says leadership turnover won’t derail push for faster US drug trials
    The Food and Drug Administration has faced a wave of leadership changes this year, creating uncertainty about its ability to keep drug development moving quickly. Industry leaders and regulators, h…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • US says Ebola patients will be evacuated to Europe, not treated in America, as outbreak grows
    The World Health Organization is reviewing which vaccines could help curb the expanding Ebola outbreak in Africa. The U.S. government announced it will no longer bring Americans infected with Ebol…
    STAT · 3mo agoRegulatoryNegative↗ source
  • XPRIZE Healthspan launches $101 million competition to test anti-aging therapies in older adults
    Jamie Justice, former Wake Forest professor, now leads XPRIZE Healthspan, a global contest aimed at finding treatments that can restore muscle, cognition and immune function in older people. The c…
    STAT · 3mo agoPositive↗ source