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  • Sionna's CF add-on pill fails to improve outcomes in Phase 2 trial with Trikafta
    Sionna Therapeutics reported that its experimental cystic fibrosis pill, SION-719, did not provide any additional benefit when combined with Vertex Pharmaceuticals' Trikafta in a Phase 2 study. Th…
    STAT · 1d agoNegative readoutNegative↗ source
  • Trump orders MMR vaccine to be administered as three separate shots, citing autism concerns
    President Donald Trump announced via an executive order that the combined measles, mumps and rubella (MMR) vaccine should be split into three individual injections for children. He claimed the cha…
    Endpoints · 19h agoRegulatoryNegative↗ source
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  • Trump administration issues executive order questioning childhood vaccine schedule
    The White House unveiled a new executive order that challenges the established childhood vaccine schedule. President Trump announced the measure from the Oval Office, marking a shift after months o…
    STAT · 20h agoRegulatoryNegative↗ source
  • FDA rejects ITM's radiopharma drug for neuroendocrine tumors over manufacturing issues
    The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical candidate from ITM Isotope Technologies Munich intended for treating neuroendocrine tumors. The agency cited manu…
    Endpoints · 21h agoRegulatoryNegative↗ source
  • Bristol Myers Squibb announces $2.3 billion manufacturing campus in Houston
    Bristol Myers Squibb disclosed plans to build a new manufacturing campus in Houston, Texas, with an estimated cost of $2.3 billion. The campus will expand the company's domestic production capacit…
    Endpoints · 21h agoDealPositive↗ source
  • Federal judge suspends Pentagon's designation of WuXi AppTec as a Chinese military-linked firm
    A U.S. district judge has temporarily halted the Pentagon’s effort to label WuXi AppTec as a company with ties to the Chinese military. The ruling was issued by Judge James Boasberg, who found the…
    Endpoints · 22h agoRegulatoryNeutral↗ source
  • Sionna’s cystic fibrosis candidate misses primary endpoint in Phase 2 trial, shares plunge
    Sionna Therapeutics announced that its experimental cystic fibrosis drug SION-719 failed to meet the primary endpoint in a Phase 2 trial that added the drug to Vertex Pharmaceuticals' Trikafta. Th…
    BioPharma Dive · 23h agoNegative readoutNegative↗ source
  • Sionna Therapeutics reports early-stage cystic fibrosis trial failure, dampening challenge to Vertex
    Sionna Therapeutics said its lead cystic fibrosis drug did not meet primary endpoints in an early-stage study, marking a setback for the company. The result reduces expectations that Sionna could…
    Endpoints · 1d agoNegative readoutNegative↗ source
  • FDA rejects ITM-11 radiopharmaceutical over manufacturing flaws, halting rival to Novartis therapy
    The U.S. Food and Drug Administration issued a rejection letter for ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich, citing manufacturing problems that prevent ap…
    STAT · 1d agoRegulatoryNegative↗ source
  • Sanofi faces shortage of two Pompe disease drugs after FDA flags manufacturing issues
    Sanofi has reported a shortage of two medicines used to treat Pompe disease. The shortage emerged after the U.S. Food and Drug Administration issued a warning about manufacturing problems at the co…
    STAT · 1d agoRegulatoryNegative↗ source
  • Tenax Therapeutics’ heart-failure drug misses primary goal in Phase 3 trial, shares tumble
    Tenax Therapeutics announced that its experimental oral levosimendan failed to meet the primary efficacy endpoint in the Phase 3 LEVEL study, which evaluated treatment for a form of heart failure l…
    STAT · 1d agoNegative readoutNegative↗ source
  • Silence Therapeutics moves siRNA drug for polycythemia vera to Phase 3 after Phase 2 success
    Silence Therapeutics announced that its siRNA candidate divesiran achieved its primary endpoint in a Phase 2 study in patients with polycythemia vera, a rare blood cancer. The trial results showed…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Silence Therapeutics’ divesiran shows 88% response in Phase 2 polycythemia vera trial, challenging Takeda’s upcoming drug
    Silence Therapeutics reported results from a Phase 2 study of its RNA-based therapy divesiran in patients with polycythemia vera, a rare blood cancer that causes excessive red blood cell production…
    STAT · 1d agoPositive readoutPositive↗ source
  • Global Ebola preparedness fixated on one strain, leaving other species vulnerable
    In an opinion piece, infectious-diseases physician Krutika Kuppalli and virologist Placide Mbala argue that the term "Ebola" masks several distinct virus species, each with different diagnostic and…
    STAT · 1d agoNegative↗ source
  • Safety concerns emerge as radiopharmaceuticals advance in cancer trials
    Radiopharmaceuticals are being hailed for their ability to deliver radiation directly to tumours, potentially sparing surrounding healthy tissue and improving cancer therapy. However, as more cand…
    STAT · 1d agoNegative↗ source
  • Global Ebola preparedness fixated on one strain, leaving gaps for other species
    Krutika Kuppalli, a former WHO medical officer, and virologist Placide Mbala write that the world’s readiness for Ebola has been narrowly focused. They draw on Kuppalli’s experience in the 2014‑201…
    STAT · 1d agoNegative↗ source
  • China clamps down on investigator-initiated clinical trials, tightening oversight
    China has announced tighter oversight of investigator-initiated trials (ITTs), requiring these studies to obtain approval from the National Medical Products Administration before they can begin. Th…
    STAT · 1d agoRegulatoryNeutral↗ source
  • RevMed partners with BeOne for Asian rights to RAS drugs as MoonLake reports Phase 3 success
    RevMed and BeOne have entered a partnership granting BeOne rights to commercialize RevMed’s RAS pathway drugs in selected Asian markets. The agreement also includes collaboration on upcoming clini…
    Endpoints · 1d agoDealPositive↗ source
  • FDA to require companies to notify agency of new food additives, creating public database
    The Health and Human Services Department announced a new policy that obligates manufacturers to inform the FDA when they introduce a new substance into human or animal food, and to explain how they…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Calls to Ban Prior Authorizations Amid Hospital Job Cuts Highlight Health‑Care Policy Debate
    The Health Care Inc. newsletter from STAT highlighted a proposal to eliminate most prior authorizations, a requirement that insurers use to control drug spending. The suggestion comes from policy…
    STAT · 1d agoNeutral↗ source
  • BioNTech veteran secures $25M seed round for virtual cancer surveillance startup
    A new virtual cancer surveillance company has closed a $25 million seed round, with the funding led by investors attracted to its novel approach to monitoring tumors. The company is headed by Ryan…
    Endpoints · 1d agoDealPositive↗ source
  • Early regulatory operations planning key to submission-ready dossiers
    Regulatory operations are often treated as a final step after all scientific data are compiled, but the article argues they should be integrated from the start of a development program. A dossier…
    BioPharma Dive · 1d agoRegulatoryPositive↗ source
  • Scholar Rock removes Indiana manufacturing site from SMA drug application after FDA cites deficiencies
    Scholar Rock, a Massachusetts biotech, announced it is withdrawing an Indiana manufacturing facility from its filing for a prospective spinal muscular atrophy (SMA) therapy. The decision follows a…
    Endpoints · 23h agoRegulatoryNegative↗ source
  • States urged to use low-cost, scalable outreach for Medicaid enrollees facing 2027 eligibility changes
    States must begin notifying Medicaid beneficiaries about upcoming eligibility changes by September, as required by the One Big Beautiful Bill Act of 2025. The changes, set to take effect in 2027, i…
    STAT · 1d agoNeutral↗ source
  • Aspo Oyj announces upcoming leadership changes scheduled for August 10, 2026
    Aspo Oyj, a Finnish specialty chemicals company, issued a brief notice indicating that it will implement leadership transactions. The announcement specifies that the changes will take effect on Au…
    globenewswire health · 1d agoNeutral↗ source