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  • Experts urge FDA to boost transparency of complete response letters and refine master protocol guidance
    A recent paper in the Journal of Law and the Biosciences outlines ways the FDA could better disclose complete response letters to the public, aiming to increase transparency for stakeholders. Indu…
    raps · 11d agoRegulatoryNeutral↗ source
  • Trump announces nine voluntary drug pricing agreements with mid-size biotech firms
    On August 31, 2026, the White House announced that President Donald Trump has secured nine new voluntary drug-pricing agreements with mid-size biotechnology companies. The companies entered the de…
    Endpoints · 10d agoDealNeutral↗ source
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  • Industry insiders invited to take Q3 BioPharma Sentiment Survey
    Signal's Endpoints team is launching the third quarterly BioPharma Sentiment Index (BPSI) survey, a three minute questionnaire that captures industry views. The survey asks participants to share p…
    Endpoints · 10d agoNeutral↗ source
  • Industry and patient groups urge FDA to revise master protocol guidance
    Industry groups and patient advocacy organizations have written to the U.S. Food and Drug Administration asking for several revisions to its recently updated draft guidance on master protocols for…
    raps · 11d agoRegulatoryNeutral↗ source
  • India streamlines regulations for outsourced medical device sterilization
    The Indian government announced a simplification of the regulatory framework governing outsourced sterilization of medical devices. The move is part of a broader effort to make it easier for busine…
    raps · 11d agoRegulatoryPositive↗ source
  • AstraZeneca’s oral relaxin drug shows partial success in mid-stage heart-failure trial
    AstraZeneca reported that its oral relaxin agonist improved cardiac function in a subset of patients enrolled in a mid-stage heart‑failure study. The trial demonstrated measurable benefits for some…
    Endpoints · 12d agoPositive readoutPositive↗ source
  • Arrowhead's RNAi drug Redemplo shows safety advantage over Ionis in late-stage triglyceride trials
    At the European Society of Cardiology meeting in Munich, Arrowhead Pharmaceuticals presented new data on its RNA interference candidate Redemplo. Redemplo was evaluated in two late-stage studies i…
    Endpoints · 11d agoPositive readoutPositive↗ source
  • FDA grants approval to Revolution Medicines' Rasonque for pancreatic cancer
    The U.S. Food and Drug Administration has approved Rasonque, a new therapy from Revolution Medicines, for the treatment of pancreatic cancer. The decision follows data that showed the drug nearly…
    Endpoints · 13d agoApprovalPositive↗ source
  • Novartis launches Phase 3 trial of IL-6 antibody to test cardiovascular benefit despite Novo's setback
    Novartis announced it will begin a Phase 3 study evaluating its anti-IL-6 monoclonal antibody in patients at high cardiovascular risk. The trial aims to determine whether reducing inflammation thr…
    Endpoints · 13d agoNeutral↗ source
  • Eli Lilly’s Mounjaro receives FDA approval to lower cardiovascular risk; Teva announces acquisition of approved drug
    Eli Lilly’s once‑a‑diabetes blockbuster tirzepatide, marketed as Mounjaro, was granted FDA approval on Friday for an indication that reduces the risk of major cardiovascular events. The approval e…
    Endpoints · 13d agoApprovalPositive↗ source
  • Eli Lilly's Mounjaro gets FDA approval to cut heart attack, stroke risk in type 2 diabetes
    The U.S. Food and Drug Administration has approved Eli Lilly's Mounjaro for reducing the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes who are at high risk fo…
    BioSpace · 13d agoApprovalPositive↗ source
  • Phase 3 trial shows Wainua fails to improve outcomes in ATTR-CM, hazard ratio 1.14
    AstraZeneca and Ionis Pharmaceuticals presented detailed results from the Phase 3 trial of their antisense oligonucleotide Wainua (eplontersen) in patients with transthyretin-mediated amyloid cardi…
    BioSpace · 13d agoNegative readoutNegative↗ source
  • FDA approves Priovant's Lisraya (brepocitinib) for rare skin disease dermatomyositis
    The U.S. Food and Drug Administration has cleared the first oral targeted treatment for dermatomyositis, a rare and disabling skin disorder. The medication, brepocitinib, will be sold under the br…
    BioPharma Dive · 13d agoApprovalPositive↗ source
  • Priovant's Lisraya receives first FDA approval as oral therapy for dermatomyositis
    The U.S. Food and Drug Administration has cleared Priovant Therapeutics' daily TYK2/JAK1 inhibitor tablet, marketed under the name Lisraya, for the treatment of dermatomyositis in adults. Lisraya…
    BioSpace · 13d agoApprovalPositive↗ source
  • AstraZeneca and Ionis gene silencer Wainua fails trial after patients also took Pfizer heart drug
    At the ESC Congress in Munich, a high‑profile trial of the gene‑silencing therapy Wainua, developed by AstraZeneca and Ionis, was reported to have failed. The failure was linked to participants co…
    Endpoints · 14d agoNegative readoutNegative↗ source
  • BioNTech stops Phase 2 colorectal cancer mRNA vaccine trial after futility findings
    BioNTech announced that it is ending its Phase 2 study of a personalized mRNA vaccine for resected colorectal cancer after the trial failed to show the needed benefit. The news sent the company’s s…
    BioSpace · 13d agoNegative readoutNegative↗ source
  • FDA clears updated COVID shots from Pfizer, Moderna and Novavax as Moderna raises $2.6 billion for cancer programs
    The FDA has granted limited approvals for updated versions of three COVID-19 vaccines aimed at the newly dominant XFG variant. The clearances cover Pfizer/BioNTech’s Comirnaty, Moderna’s mNEXSPIKE…
    BioPharma Dive · 13d agoRegulatoryPositive↗ source
  • BioXcel files for Chapter 11 bankruptcy, selling assets to Teva for up to $125 M
    BioXcel Therapeutics announced it has filed for Chapter 11 bankruptcy and plans to sell all of its assets. Teva Pharmaceuticals will serve as the stalking horse bidder, proposing an upfront paymen…
    BioSpace · 13d agoDealNegative↗ source
  • AstraZeneca and Amgen’s Tezspire eyes Dupixent’s EoE stronghold after late-stage trial win
    Analysts note that AstraZeneca and Amgen have secured a late‑stage trial win for Tezspire, positioning the drug as a possible challenger to Dupixent in eosinophilic esophagitis (EoE). Dupixent re…
    BioSpace · 13d agoPositive readoutPositive↗ source
  • FDA greenlights Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera
    The U.S. Food and Drug Administration has granted approval to rusfertide, a therapy developed jointly by Takeda Pharmaceutical and Protagonist Therapeutics. The drug, to be marketed under the name…
    Endpoints · 13d agoApprovalPositive↗ source
  • BioNTech and Genentech halt Phase 2 trial of personalized mRNA cancer vaccine
    BioNTech and its partner Genentech announced the termination of a Phase 2 study evaluating a personalized mRNA cancer vaccine. The decision was made shortly after the trial had entered its second s…
    Endpoints · 13d agoNegative↗ source
  • CRISPR Therapeutics to test highest dose of lipid‑lowering gene editing therapy after mixed durability data
    CRISPR Therapeutics presented early‑stage data at the European Society of Cardiology meeting showing that its lipid‑lowering gene editing candidate produced mixed durability results a year after pa…
    Endpoints · 13d agoNegative readoutNeutral↗ source
  • Biotech Index Surges as IPOs and M&A Activity Accelerate in 2026
    The XBI biotech index, which had fallen to about $64 per share three years ago, has climbed back to near $170, almost doubling its value over the past year. Investor interest is reflected in a wav…
    BioPharma Dive · 13d agoPositive↗ source
  • Roche commits over $1 billion to DualityBio for ADC development targeting TOP1 resistance
    Roche's Genentech unit announced a major investment in DualityBio to advance antibody-drug conjugate (ADC) technology. Under the agreement DualityBio will receive an upfront payment of $45 million…
    Endpoints · 13d agoDealPositive↗ source
  • Cytokinetics aims for broader Myqorzo approval next year after supportive trial data
    Cytokinetics reported new data on its cardiac therapy Myqorzo, presented at a European scientific meeting. The results reinforce the drug’s efficacy in a specific heart muscle disorder. The compan…
    Endpoints · 14d agoApprovalPositive↗ source