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591 stories matching this filter · ← front page

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  • FDA grants accelerated approval to Vera Therapeutics' Trutakna for IgA nephropathy
    The FDA has granted accelerated approval to Trutakna (formerly known as atacicept) from Vera Therapeutics for adult patients with IgA nephropathy, a chronic kidney disease that can progress to rena…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • Vertex to buy Crinetics for $10 billion, adding acromegaly drug Palsonify
    Vertex Pharmaceuticals announced a $10 billion acquisition of Crinetics Pharmaceuticals, marking the largest deal in Vertex’s history. The purchase gives Vertex control of Crinetics’ marketed ther…
    STAT · 3mo agoDealPositive↗ source
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  • Novartis to buy Myricx Bio for up to $1.5 billion, adding two novel ADCs to its oncology portfolio
    Novartis announced it will acquire Myricx Bio, a UK‑based biotech that develops antibody drug conjugates (ADCs), in a move to broaden its oncology pipeline. The transaction is valued at up to $1.5…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Novartis to buy Myricx Bio for $1.1 billion as Medicare proposes steep 340B cuts and other biotech policy updates
    Novartis announced it will acquire UK‑based Myricx Bio for an upfront $1.1 billion, adding an antibody‑drug conjugate platform aimed at solid‑tumor cancers. The agreement also includes potential mi…
    STAT · 3mo agoDealNeutral↗ source
  • Anthropic CEO says AI’s biotech breakthrough may still be a decade away despite current hype
    In a recent on‑stage conversation, Matthew Herper interviewed Dario Amodei, the CEO and co‑founder of Anthropic, about the role of artificial intelligence in biotechnology. The discussion took plac…
    STAT · 3mo agoNeutral↗ source
  • GOP lawmakers urge FDA under Trump to enforce diversity in clinical trial enrollment
    Republican members of Congress have asked the Food and Drug Administration, now led by President Trump, to adopt policies that require clinical trials to enroll participants who reflect the diversi…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Roche’s divarasib shows survival benefit over Amgen and BMS drugs in KRAS G12C lung cancer trial
    Roche reported that its experimental KRAS G12C inhibitor divarasib extended overall survival and progression‑free survival in a Phase 3 head‑to‑head study against Amgen’s Lumakra and Bristol Myers…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Roche's KRAS G12C inhibitor divarasib outperforms Amgen and Bristol Myers Squibb drugs in Phase 3 head-to-head trial
    Roche announced that its KRAS G12C inhibitor divarasib showed superiority over existing marketed therapies from Amgen and Bristol Myers Squibb in a Phase 3 head-to-head trial in lung cancer. The t…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Celea Therapeutics raises $180 million to advance next-generation IPF drug deupirfenidone
    Celea Therapeutics, a PureTech Health spinout, announced a $180 million venture round to fund development of its next-generation idiopathic pulmonary fibrosis (IPF) therapy, deupirfenidone. The ro…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Roche announces drug that sets new benchmark for KRAS‑driven lung cancer
    Roche has announced a new therapy that it says establishes a new standard of care for patients with KRAS‑driven lung cancer. The announcement was featured in a STAT+ newsletter, underscoring the p…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Celea Therapeutics secures $180M financing to advance IPF pipeline
    Celea Therapeutics, an idiopathic pulmonary fibrosis (IPF) biotech, announced it has raised $180 million from a group of new investors. The funding is intended to help the company follow the devel…
    Endpoints · 3mo agoDealNeutral↗ source
  • CDC leadership accused of stifling vaccine effectiveness studies and reshaping advisory committee role
    Ben Lopman, a professor of epidemiology and global health at Emory University, wrote an opinion piece warning that CDC leadership is trying to manufacture a scientific debate about vaccines where n…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Hamilton Medical issues updated use instructions for certain breathing circuit sets after serious recall
    Hamilton Medical has sent a letter to customers on May 18, 2026, advising updated use instructions for specific coaxial breathing circuit sets used with its HAMILTON-C1, HAMILTON T-1 and HAMILTON-M…
    fda medwatch · 3mo agoCRLNegative↗ source
  • Loss of Colorado Rep. Diana DeGette removes a knowledgeable voice for biopharma in Congress
    Colorado Democratic Rep. Diana DeGette was defeated in her primary, ending her service in the U.S. House of Representatives. DeGette was widely recognized for her deep understanding of biopharma p…
    STAT · 3mo agoNegative↗ source
  • Ebola and Marburg outbreaks highlight need for pathogen-agnostic diagnostics
    The authors describe a current Bundibugyo Ebola outbreak affecting the Democratic Republic of Congo and Uganda, which has resulted in more than 1,300 confirmed cases and over 375 deaths. While the…
    STAT · 3mo agoNegative↗ source
  • FDA permits Zyn nicotine pouches to be marketed as safer than cigarettes
    The U.S. Food and Drug Administration announced that Zyn's nicotine pouches can be advertised as a safer alternative to traditional cigarettes. The decision reflects the agency's view that the pouc…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Biotech sector eyes key clinical trial readouts in H2 2026 across cancer, Alzheimer’s and autoimmune diseases
    The first half of 2026 saw a surge in biotech activity, with record‑high deal flow, several large IPOs and a regulatory environment that appears to be stabilising after a period of uncertainty. An…
    BioPharma Dive · 3mo agoNeutral↗ source
  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 3mo agoRegulatoryPositive↗ source
  • Theravance, after clinical setbacks, agrees to $929M buyout
    The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • FDA advisory panel backs Moderna's experimental flu vaccine in adults 50-64, supports accelerated review for 65+
    The FDA's advisory committee voted unanimously to recommend Moderna's mRNA-1010 flu vaccine for adults aged 50 to 64, and also found it beneficial for those 65 and older. The 9-0 vote allows Moder…
    BioPharma Dive · 4mo agoRegulatoryPositive↗ source
  • cAMPfield Therapeutics raises $180 million to develop oral IBD drug prifemilast
    cAMPfield Therapeutics, a California biotech, announced a $180 million Series A financing to advance its oral anti‑inflammatory candidate for inflammatory bowel disease. The investigational drug,…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Pfizer CFO Dave Denton to leave; Denali Therapeutics sells $195 million FDA priority review voucher
    Pfizer announced that its chief financial officer Dave Denton will depart on Aug. 15 to take a role outside the pharmaceutical sector. He has been CFO since May 2022. In the interim, finance chief…
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • Former Senators Urge Congress to Prioritize Global Health as Strategic Diplomacy
    The authors, former U.S. senators, argue that improving global health must become a top priority for the United States, especially in light of recent outbreaks such as hantavirus and Ebola, which l…
    STAT · 4mo agoPositive↗ source
  • AI's rising electricity and water demand poses a public health risk, authors warn
    Two public-health scholars argue that the expanding use of artificial intelligence is creating a hidden strain on essential services such as electricity and water. They note that the massive data c…
    STAT · 4mo agoNegative↗ source
  • FDA staff raise concerns over data for Moderna’s mFlusiva flu vaccine ahead of advisory panel
    FDA staff have examined the evidence for Moderna's mFlusiva, an mRNA flu vaccine, and highlighted shortcomings in the data submitted to the agency. The Food and Drug Administration will convene an…
    BioPharma Dive · 4mo agoRegulatoryNegative↗ source