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165 stories matching this filter · ← front page

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  • Solstice Oncology secures $225M Series A to advance CTLA-4 antibody porustobart in colon cancer
    Solstice Oncology, a biotech startup focused on immunotherapy, announced it has raised $225 million in a Series A financing round. The funding will support development of its lead candidate, a CTL…
    BioPharma Dive · 23h agoDealPositive↗ source
  • Tyra Biosciences’ bladder cancer pill misses expected response rate in Phase 2 trial
    Shares of Tyra Biosciences dropped about 20% after data from its Phase 2 study of a bladder cancer pill fell short of market expectations. The experimental drug, dabogratinib, is taken daily and t…
    BioPharma Dive · 14h agoNegative readoutNegative↗ source
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fda medwatch66
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fda press38
873
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Endocrinology & Metabolism483
Infectious Disease451
  • Kura Oncology launches Caspian Therapeutics to develop menin-inhibitor diabetes drug with $50M funding
    Kura Oncology has spun out a new biotech called Caspian Therapeutics to focus on menin inhibitors for diabetes and other cardiometabolic diseases. The company’s lead candidate, code-named KO-7246,…
    BioPharma Dive · 18h agoDealPositive↗ source
  • Roivant reports record-breaking Phase 2 results for PH-ILD drug mosliciguat, starts Phase 3
    Roivant announced that its experimental drug mosliciguat met all primary and secondary endpoints in a Phase 2 study in patients with pulmonary hypertension associated with interstitial lung disease…
    BioPharma Dive · 1d agoPositive readoutPositive↗ source
  • BrainChild secures $116M to advance CAR-T therapies for rare pediatric brain tumors
    BrainChild Bio, a Seattle‑based biotech spun out of Seattle Children’s Hospital, announced it has raised $116 million in venture financing. The capital will fund the development of its CAR‑T cell t…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Ionis receives FDA approval for Zanvastro, the first treatment for Alexander disease, as Pfizer partners on new ADC program
    The U.S. Food and Drug Administration approved Zanvastro, marking the first approved medicine for the rare and often fatal neurological disorder Alexander disease. Developed by Ionis Pharmaceutical…
    BioPharma Dive · 5d agoApprovalPositive↗ source
  • AbbVie’s dual-acting myeloma drug etentamig meets main Phase 3 goal, showing longer progression-free survival
    AbbVie announced that its bispecific antibody etentamig achieved the primary endpoint in a Phase 3 trial for patients with multiple myeloma who have progressed after two or more prior therapies. Th…
    BioPharma Dive · 5d agoPositive readoutPositive↗ source
  • Licensing deals with Chinese biotech stay strong as big pharma pours $550M+ into cancer and obesity pipelines
    Western drug developers continue to sign licensing agreements with Chinese biotechnology firms at a steady pace, according to recent data visualizations. More than 100 such deals have been announc…
    BioPharma Dive · 5d agoDealNeutral↗ source
  • GSK to spend up to $1.3 billion on Hutchmed's dual-target cancer therapy
    GSK announced a deal to acquire the majority rights to Hutchmed's experimental therapy HMPL-A830. The agreement includes an upfront payment of $110 million and potential milestone and royalty payme…
    BioPharma Dive · 6d agoDealNeutral↗ source
  • Akeso's ivonescimab shows survival advantage over Keytruda in Chinese lung cancer trial
    A new data cut from a study comparing ivonescimab, a bispecific antibody from China-based Akeso, with Merck's Keytruda in patients with non-small cell lung cancer was released. The interim results…
    BioPharma Dive · 6d agoPositive readoutPositive↗ source
  • Novartis and Bristol Myers pause autoimmune CAR-T trials after serious safety events
    Novartis and Bristol Myers Squibb announced the suspension of several autoimmune CAR‑T studies after encountering serious safety problems. In Novartis' trials, three participants died from a severe…
    BioPharma Dive · 7d agoNegative readoutNegative↗ source
  • Teva reports positive mid-stage results for celiac disease antibody, BioMarin settles patent fight with Ascendis
    Teva said its experimental antibody TEV-408 showed statistically significant and clinically meaningful reduction in gluten-induced intestinal damage in a mid-stage trial for celiac disease. The tr…
    BioPharma Dive · 7d agoPositive readoutPositive↗ source
  • Novartis reports Phase 3 success for MS pill remibrutinib, beats Aubagio and shows no liver safety issues
    Novartis announced that its BTK inhibitor remibrutinib met primary endpoints in two Phase 3 trials in patients with relapsing multiple sclerosis. The studies showed the drug reduced annualized rel…
    BioPharma Dive · 8d agoPositive readoutPositive↗ source
  • Mid-size biotechs join White House Medicaid pricing program, gain tariff relief
    Nine mid-size drugmakers announced they will take part in the White House’s GENEROUS Medicaid pricing model, which ties U.S. Medicaid payments to the lowest prices paid abroad. In return, the comp…
    BioPharma Dive · 8d agoRegulatoryNeutral↗ source
  • FDA clears Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera, opening potential $2 billion market
    The Food and Drug Administration has granted clearance to rusfertide, sold under the brand name Mimrylo, for the treatment of polycythemia vera, a rare blood disorder that causes excess red blood c…
    BioPharma Dive · 9d agoApprovalPositive↗ source
  • Novartis and Bristol Myers pause autoimmune CAR-T trials after safety concerns
    Novartis announced a temporary hold on its personalized CAR-T therapy rap-cel after three patients experienced immune effector cell-associated hemophagocytic syndrome, a rare and potentially life-t…
    BioPharma Dive · 9d agoRegulatoryNegative↗ 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 · 12d agoRegulatoryPositive↗ 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 · 13d agoApprovalPositive↗ source
  • Outer Bio unveils skin‑tissue platform that keeps samples alive for a month, creating terabytes of data for skincare research
    Outer Bio, a new biotech founded by Michael Polansky, has emerged from stealth to offer a skin‑focused platform that maintains harvested human skin tissue alive for about a month. The company says…
    BioPharma Dive · 13d agoPositive↗ source
  • FDA grants rapid approval to Revolution Medicines' pancreatic cancer drug Rasonque
    FDA approved Revolution Medicines' pancreatic cancer therapy Rasonque, just over a month after submission using a priority review voucher. The drug, formerly known as daraxonrasib, is for patients…
    BioPharma Dive · 14d agoApprovalPositive↗ source
  • Study finds Lilly's obesity drug Zepbound may lower hospital and ER costs for older adults
    A real‑world analysis examined older patients with obesity or excess weight who were either treated with Eli Lilly’s drug Zepbound or not. The researchers tracked healthcare utilization over time t…
    BioPharma Dive · 14d agoPositive readoutPositive↗ source
  • FDA expands Jazz's Ziihera to frontline HER2-positive gastroesophageal cancers, unlocking $1.5 billion market
    The U.S. Food and Drug Administration has broadened the approved use of Jazz Pharmaceuticals' cancer therapy Ziihera. The drug can now be given as an initial treatment for patients with HER2‑positi…
    BioPharma Dive · 15d agoApprovalPositive↗ source
  • FDA places second clinical hold on Regenxbio’s Hunter syndrome gene therapy after spinal masses detected
    The FDA issued another clinical hold on Regenxbio’s RGX-121 gene therapy for Hunter syndrome after investigators found spinal masses in five trial participants. The masses, observed on MRI scans,…
    BioPharma Dive · 16d agoRegulatoryNegative↗ source
  • FDA pushes back decision on Capricor’s Duchenne cell therapy, GSK clears hepatitis B drug in Japan
    The U.S. Food and Drug Administration has extended its review of Capricor Therapeutics' experimental Duchenne muscular dystrophy cell therapy, deramiocel. The agency moved its decision deadline fro…
    BioPharma Dive · 16d agoRegulatoryNeutral↗ source
  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 20d agoPositive readoutPositive↗ source