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  • 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 · 1mo agoRegulatoryPositive↗ 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 · 1mo agoPositive↗ source
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  • 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 · 1mo agoRegulatoryNeutral↗ 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 · 1mo agoApprovalPositive↗ source
  • AstraZeneca and Amgen report positive Phase 3 results for Tezspire in eosinophilic esophagitis
    AstraZeneca and Amgen announced that their joint drug Tezspire met primary and secondary endpoints in a late-stage Phase 3 trial for eosinophilic esophagitis. The antibody targets TSLP and had pre…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ 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 · 1mo 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 · 1mo agoApprovalPositive↗ source
  • Biohaven sells rights to its lead epilepsy drug opakalim to SK Biopharma for up to $795 million
    Biohaven announced it will transfer the rights to its most advanced experimental therapy for focal epilepsy, known as opakalim, to South Korean company SK Biopharma. The agreement could bring as m…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Spyre shares plunge as rheumatoid arthritis trial of SPY072 falls short of internal target
    Spyre Therapeutics reported that its antibody SPY072 did not meet the company’s internal criteria in a mid‑stage rheumatoid arthritis trial, despite showing some activity. The placebo‑controlled s…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ 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 · 1mo 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 · 1mo agoApprovalPositive↗ source
  • FDA clears Roche and Eli Lilly's blood test for early Alzheimer’s detection
    The U.S. FDA has granted clearance for a new blood test developed by Roche and Eli Lilly that measures phosphorylated tau 217 (pTau217) to help rule in or rule out Alzheimer’s disease. The Elecsys…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Venture funding for women’s health startups drops sharply after 2024 peak, AI may drive rebound
    Venture capital flowing into women’s health companies fell sharply after reaching record levels in 2024. A Silicon Valley Bank report shows total funding dropped from about $3.2 billion in 2024 to…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Massachusetts biotech startups see funding gap widen as seed rounds shrink and Series A deals surge
    A MassBio report shows that mature biotech firms in Massachusetts captured most of the venture capital in the first half of 2026, with nearly $3.5 billion invested, a 25% rise from the same period…
    BioPharma Dive · 1mo agoNeutral↗ 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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ source
  • Roche to acquire Hanmi's lean-mass preserving obesity shot in $2.3 bn deal
    Roche announced a partnership with South Korean company Hanmi Pharm to obtain rights to a novel obesity drug outside South Korea. Under the agreement, Roche will pay $190 million upfront and could…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Pharma marketers urged to adopt share-of-answer strategy as AI use surges among physicians
    Pharma marketers are planning for 2027 as artificial intelligence reshapes how clinicians seek clinical answers. The rise of AI tools means that traditional metrics like share of voice and broad om…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Cellares to cut 100 jobs after losing contract with unnamed large pharma customer
    Cellares, a cell therapy manufacturing startup based in South San Francisco, announced it will lay off about 100 employees. The cuts follow the termination of a contract by an unnamed large pharma…
    BioPharma Dive · 1mo agoLayoffsNegative↗ source
  • Lilly leads GLP-1 weight-loss market while Novo Nordisk’s Wegovy exceeds expectations but falls short of forecasts
    Eli Lilly and Novo Nordisk are intensifying their battle for dominance in the multibillion‑dollar GLP‑1 weight‑loss market, with each company promoting its own set of injectable therapies and pipel…
    BioPharma Dive · 2mo agoEarningsNeutral↗ source
  • Activist Kaos Capital pushes governance overhaul at Capricor ahead of FDA Duchenne decision
    Activist investor Kaos Capital has sent a letter to Capricor Therapeutics shareholders demanding a “governance reset.” The firm asks for a meeting to nominate two independent directors, create an M…
    BioPharma Dive · 2mo agoNegative↗ 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 · 2mo agoPositive readoutPositive↗ source
  • Ultragenyx secures FDA approval for Glenglycos, first gene therapy for GSD Ia
    Ultragenyx announced FDA approval of Glenglycos, a one-time gene therapy for glycogen storage disease type Ia, a rare genetic disorder. The therapy delivers a functional gene to the liver to resto…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • Regeneron wins FDA approval for Pasatru, targeting rare bone disease FOP
    The U.S. Food and Drug Administration has approved Regeneron Pharmaceuticals' drug Pasatru for the treatment of fibrodysplasia ossificans progressiva (FOP), a very rare condition in which muscle an…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • Moderna-Merck mRNA cancer vaccine shows landmark interim success in melanoma trial
    An interim analysis of a Phase 3 trial of an individualized mRNA cancer vaccine from Moderna and Merck showed the treatment met its primary goals. The vaccine, given together with Merck's immunothe…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source