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1,498 stories matching this filter · ← front page

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  • Sanofi-backed Electra Therapeutics files for Nasdaq IPO to fund Phase 2/3 immunology program
    Electra Therapeutics announced it has filed with securities regulators to begin trading on the Nasdaq shortly after the Labor Day holiday. The Sanofi-backed biotech aims to raise capital through t…
    Endpoints · 11d agoDealPositive↗ source
  • Verily, NVIDIA and NIH launch first multimodal AI model combining EHR and genomics
    Verily Health, in partnership with NVIDIA and the NIH All of Us Research Program, announced the development of a new foundation model that merges electronic health record data with genomic informat…
    BioPharma Dive · 11d agoPositive↗ source
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  • 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 · 11d agoDealNeutral↗ 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 · 11d agoNeutral↗ 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 · 13d 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 · 12d 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 · 14d 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 · 14d 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 · 14d 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
  • 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 · 14d agoRegulatoryPositive↗ 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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
  • FDA alerts on possible Aspergillus contamination in Avid Medical IV start kits
    The FDA’s Center for Devices and Radiological Health has issued an Early Alert warning that certain IV start kits from Avid Medical may be contaminated with the fungus Aspergillus penicillioides, a…
    fda medwatch · 15d agoRegulatoryNegative↗ source
  • Boston Scientific recalls Imager II angiographic catheters over tip detachment risk
    FDA's CDRH issued an Early Alert about Boston Scientific's Imager II angiographic catheters due to a manufacturing problem that can cause the catheter tip to detach. The company sent a letter on A…
    fda medwatch · 15d agoRegulatoryNegative↗ source
  • AstraZeneca, Ionis data spark debate about RNA drugs’ impact on deadly heart disease
    Results published in NEJM raised questions about the benefits “silencer” medications provide on top of standard therapies for TTR cardiomyopathy and amplified investor pressure on Alnylam.
    BioPharma Dive · 14d agoRegulatoryNeutral↗ source
  • Daiichi Sankyo to restructure its commercial organization, appointing Ken Keller as chief commercialization officer
    Daiichi Sankyo announced plans to overhaul its commercial operations, with a split of its commercialization activities slated for April 1, 2027. The company has appointed veteran executive Ken Kel…
    Endpoints · 14d agoNeutral↗ source
  • FDA approves Roivant's oral dermatomyositis drug Lisraya (brepocitinib)
    The U.S. Food and Drug Administration has granted approval to Roivant's drug brepocitinib, which will be sold under the brand name Lisraya. The decision marks the first major regulatory clearance f…
    Endpoints · 15d agoApprovalPositive↗ source
  • Revolution Medicines’ pancreatic cancer drug Rasonque priced at $39,800 a month, analysts predict blockbuster sales after swift FDA approval
    Revolution Medicines announced that its new pancreatic cancer therapy, Rasonque, received FDA approval in a rapid review process. The drug is priced at $39,800 for a 30-day supply, which translate…
    BioPharma Dive · 15d agoApprovalPositive↗ source
  • Gilead secures another FDA approval for HIV therapy, bolstering lenacapavir portfolio
    Gilead Sciences announced that the U.S. Food and Drug Administration has approved a new HIV treatment, adding to the company's growing portfolio of antiviral drugs. The approval extends the reach o…
    Endpoints · 15d agoApprovalPositive↗ source