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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 · 7d 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 · 6d agoDealNeutral↗ source
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  • Natera partners with Angiex to evaluate Signatera blood test in AGX101 cancer trial
    Natera announced a collaboration with biotech Angiex to assess its Signatera circulating tumor DNA blood test in the context of Angiex’s early‑stage clinical trial of AGX101. Angiex, based in Camb…
    Fierce Biotech · 7d agoDealPositive↗ source
  • 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 · 7d 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have written to the U.S. Food and Drug Administration asking for several revisions to its recently updated draft guidance on master protocols for…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 · 7d 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 · 7d 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 · 8d 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 · 8d 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 · 9d 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 · 9d 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 · 10d agoApprovalPositive↗ 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 · 10d 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 · 10d 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 · 10d agoRegulatoryPositive↗ source
  • AusperBio secures $120 million Series C to push hepatitis B antisense therapy into Phase 3
    AusperBio Therapeutics announced it has closed a $120 million Series C financing round aimed at moving its hepatitis B antisense oligonucleotide candidate toward late‑stage trials and eventual mark…
    Fierce Biotech · 10d agoDealPositive↗ source
  • Roche pays $190 million for rights to Hanmi's UCN2 analog targeting obesity with muscle-preserving effects
    Roche's Genentech unit has agreed to pay $190 million upfront for rights to HM17321, a urocortin‑2 analog developed by South Korea’s Hanmi Pharmaceutical, covering markets outside South Korea. The…
    Fierce Biotech · 10d agoDealPositive↗ source
  • Genentech pays $45M upfront to DualityBio for ADC platform targeting resistant cancers
    Genentech has agreed to pay DualityBio $45 million upfront for rights to its antibody‑drug conjugate (ADC) technology, with the agreement offering more than $1 billion in potential milestone paymen…
    Fierce Biotech · 10d agoDealPositive↗ 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 · 9d 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 · 10d 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 · 10d 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 · 10d agoPositive↗ source
  • BioNTech-Genentech halts colorectal cancer vaccine trial after higher death rate in vaccine arm
    BioNTech and Genentech stopped a phase 2 trial of their personalized mRNA vaccine BNT122 in patients with stage 2 or 3 colorectal cancer after an independent data safety monitoring board found more…
    Fierce Biotech · 10d agoNegative readoutNegative↗ 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 · 10d 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 · 10d agoApprovalPositive↗ source
  • FDA sends warning to Alar over misleading claims about investigational depression drug
    The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion sent an untitled warning letter to Alar Pharmaceuticals. The agency says Alar’s promotional materials for ALA-3000, an…
    raps · 10d agoRegulatoryNegative↗ source