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  • New study warns that Trump-era cuts to federal research could jeopardize cancer drug development
    A recent study examines how recent political moves to curtail federally funded research could affect cancer drug development. The analysis notes that over the past decade biopharma companies have…
    Endpoints · 24d agoRegulatoryNegative↗ source
  • Replimune appoints former Genentech exec Michelle DiNapoli as chief commercial officer after accelerated melanoma approval
    Replimune announced that Michelle DiNapoli will become its chief commercial officer, starting August 18. DiNapoli previously held senior roles at Genentech, where she led commercial operations. Th…
    Endpoints · 24d agoPositive↗ source
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  • New study shows focal therapy matches surgery and radiation survival while reducing side effects in localized prostate cancer
    Physicians remain split over focal therapy for localized prostate cancer, a technique that targets MRI‑visible lesions with heat, cold, or other energy sources instead of removing the entire gland.…
    STAT · 24d agoPositive readoutNeutral↗ source
  • HHS Secretary RFK Jr. seeks to soften U.S. vaccine recommendations
    HHS Secretary Robert F. Kennedy Jr. has issued a request for information seeking to soften government vaccine recommendations. The request, released on Friday, signals that the administration is s…
    Endpoints · 24d agoRegulatoryNegative↗ source
  • GOP lawmakers urge FDA to reject Chinese trial data unless sites undergo recent agency audit
    Two Republican members of the U.S. House have asked the Food and Drug Administration to tighten its oversight of clinical data that originates from China. Their proposal would require the FDA to r…
    Endpoints · 24d agoRegulatoryNegative↗ source
  • California chronic pain biotech co‑founded by Vivek Ramaswamy to go public via reverse merger
    A California biotech company that has developed a chronic pain medication already approved for use in Italy is preparing to list on a U.S. exchange. The firm, co‑founded by entrepreneur Vivek Rama…
    Endpoints · 24d agoDealNeutral↗ source
  • Spruce Biosciences appoints former Zevra Therapeutics CMO Adrian Quartel
    Spruce Biosciences announced the hiring of Adrian Quartel as its new chief medical officer. Quartel joins Spruce after serving as CMO at Zevra Therapeutics, where he oversaw clinical development.…
    STAT · 24d agoNeutral↗ source
  • Lil Nas X’s bipolar diagnosis highlights the fear many high achievers have of mental-health treatment
    Lil Nas X recently revealed that he has been diagnosed with bipolar disorder. The article notes that he had suspected something was wrong for years but delayed seeking help because he was worried a…
    STAT · 24d agoNeutral↗ source
  • Regeneron’s ultra-rare bone disorder drug receives U.S. approval after 30-year development
    Regeneron Pharmaceuticals announced that its therapy for an ultra-rare condition in which bone forms in soft tissue has been approved by the U.S. Food and Drug Administration. The disease, sometim…
    STAT · 25d agoApprovalPositive↗ source
  • Merck and Moderna report positive late-stage melanoma vaccine results, adding to 2026 cancer breakthrough year
    Merck and Moderna announced that their personalized mRNA neoantigen vaccine achieved positive outcomes in a late-stage trial for melanoma patients. The data suggest the vaccine can stimulate an imm…
    STAT · 25d agoPositive readoutPositive↗ source
  • FDA approves Ultragenyx gene therapy and Regeneron ultra-rare disease drug
    The Food and Drug Administration gave the green light to a gene‑therapy product from Ultragenyx, marking a new treatment option in the company’s pipeline. In a separate decision, Regeneron secured…
    STAT · 25d agoApprovalPositive↗ source
  • Gray‑market copies of Lilly’s obesity drug retatrutide show weaker weight‑loss results, study finds
    A recent study examined the effectiveness of gray‑market versions of Eli Lilly’s triple‑agonist obesity drug retatrutide. The analysis found that patients using these unapproved copies experienced…
    Endpoints · 25d agoNegative readoutNegative↗ source
  • FDA grants approval to Ultragenyx's Genglycos gene therapy for ultra-rare glycogen storage disorder
    Ultragenyx announced that the U.S. Food and Drug Administration has approved its gene therapy called Genglycos. The therapy targets an ultra-rare glycogen storage disorder that can lead to severe…
    Endpoints · 25d agoApprovalPositive↗ source
  • Trump nominates Heidi Overton as FDA Commissioner as agency releases CGT Q&A guidance
    The U.S. Food and Drug Administration issued final guidance that answers common questions about developing cellular and gene therapy products. The document aims to clarify regulatory expectations f…
    raps · 25d agoRegulatoryNeutral↗ source
  • Three deaths in China’s investigator-initiated trials raise concerns over fast, low-cost clinical testing
    Three participants died while taking part in investigator-initiated trials in China, prompting renewed scrutiny of the country’s clinical testing practices. China’s system is prized for its low co…
    Endpoints · 25d agoRegulatoryNegative↗ source
  • Eli Lilly teams with Amplitude on taRNA vaccine platform as Otsuka ends psychedelic trial
    Eli Lilly announced a collaboration with Amplitude Therapeutics to co‑develop vaccine candidates using a trans‑amplifying RNA (taRNA) platform. The taRNA approach aims to boost antigen expression…
    Endpoints · 25d agoDealNeutral↗ source
  • Capricor Therapeutics likely faces FDA rejection of its Duchenne cell therapy
    Capricor Therapeutics is working to avoid an imminent FDA rejection of its cell‑based treatment for Duchenne muscular dystrophy. The company says it remains confident in the drug, but the regulator…
    STAT · 25d agoRegulatoryNegative↗ source
  • Capricor’s Duchenne drug deramiocel receives negative FDA advisory vote on heart outcome
    Mindy Leffler, a parent of a young man with Duchenne muscular dystrophy, writes an opinion piece about Capricor’s phase 3 study of its drug deramiocel. She describes her son’s experience living ind…
    STAT · 25d agoRegulatoryNegative↗ source
  • Health systems deploy AI chatbots to streamline patient record review
    Several large health systems are rolling out generative AI chatbots that can query and summarize electronic medical records. Clinicians report that the tools save time and help uncover information…
    STAT · 25d agoPositive↗ source
  • FDA approves Ultragenyx gene therapy for glycogen storage disorder; Overton faces confirmation hurdles
    The U.S. Food and Drug Administration has granted approval to Ultragenyx's gene therapy aimed at treating a glycogen storage disorder. This marks a regulatory milestone for the company and the rare…
    raps · 25d agoApprovalPositive↗ source
  • FDA rejects Osteal Therapeutics' combo therapy for joint-implant infections
    The U.S. Food and Drug Administration rejected Osteal Therapeutics' lead combination therapy late last month. The agency cited concerns that prevented approval of the product intended to treat infe…
    Endpoints · 25d agoRegulatoryNegative↗ source
  • Trump administration nominates Heidi Overton as FDA commissioner after acting chief declines
    The White House announced that Heidi Overton has been nominated to lead the Food and Drug Administration after acting commissioner Kyle Diamantas turned down a permanent appointment. Reports from…
    STAT · 25d agoRegulatoryNeutral↗ source
  • American Cancer Society cancels wine and spirits gala amid conflict-of-interest concerns
    The American Cancer Society announced it will not hold the planned Wine and Spirits Industry Gala after internal review highlighted a conflict of interest with the alcohol sector, which is linked t…
    STAT · 25d agoNeutral↗ source
  • PhRMA weighs former Republican lawmakers and Trump administration officials for CEO role
    PhRMA, the pharma lobbying group, has been searching for a new chief executive for over four months. The search has focused on candidates with Republican backgrounds, including former members of C…
    Endpoints · 25d agoNeutral↗ source
  • Experts call for modernizing rare disease evidence models using FDA plausible mechanism framework
    A recent paper in The Journal of Clinical Investigation argues that the evidentiary approach for rare diseases needs updating. The authors suggest applying the FDA’s plausible mechanism framework,…
    raps · 25d agoNeutral↗ source