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930 stories matching this filter · ← front page

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  • BMS CEO says firm not pressured to pursue acquisitions despite quiet M&A year
    BMS chief executive Chris Boerner told analysts on the second‑quarter earnings call that the company’s robust late‑stage pipeline means it does not feel any compulsion to chase deals. The firm has…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Labcorp reports Q2 sales of $3.73 billion, lifts full-year revenue outlook despite missing consensus
    Labcorp announced second‑quarter revenue of $3.73 billion, up from $3.53 billion a year earlier, driven by strong performance across its core businesses. The Diagnostics division grew 5.5% to $2.9…
    Fierce Biotech · 1mo agoEarningsNeutral↗ source
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fda recalls70
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Pain488
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Infectious Disease451
  • Takeda drops its second celiac disease candidate, TAK-101, after unimpressive phase 2 results
    Takeda said it is halting development of TAK-101, its second candidate for celiac disease, after a phase 2 study failed to meet expectations. TAK-101 is a nanoparticle that carries gliadin, a glut…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • GSK signs up to $110 million AI data partnership with Relation
    GSK announced a research collaboration with AI-focused biotech Relation, valued at up to $110 million. Under the agreement Relation will produce large-scale datasets that capture how human cells r…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Sanofi’s new CEO vows deeper review of late-stage pipeline after series of trial failures
    Sanofi appointed Belén Garijo as chief executive in February with a clear mandate to tighten R&D governance and boost productivity. The board tasked her with bringing more rigor to the company’s st…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Boston Scientific lowers full-year revenue outlook as restructuring plan targets slowing growth
    Boston Scientific announced on July 29 that it is cutting its 2026 full-year organic revenue growth forecast to 5-6%, down from the prior 6.5-8% range. The revision follows a second consecutive qu…
    Fierce Biotech · 1mo agoEarningsNegative↗ source
  • FDA releases FY 2027 user fee rates for prescription, generic, biosimilar, device and over the counter programs
    The U.S. Food and Drug Administration has published its user fee schedule for fiscal year 2027. The rates cover prescription drugs, generic drugs, biosimilars, medical devices and over the counter…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA releases updated guidances for injectable peptide drugs and announces FY 2027 user fee rates
    The FDA has updated 17 draft product-specific guidances aimed at helping sponsors prepare abbreviated new drug applications for injectable peptide products. The guidances cover peptide therapies u…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 Years
    A new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints r…
    raps · 1mo agoNegative↗ source
  • FDA releases FY 2027 user fee rates and updates guidance for injectable peptide ANDAs
    The U.S. Food and Drug Administration has published its user fee rates for fiscal year 2027, covering prescription drugs, generics, biosimilars, medical devices and over‑the‑counter products. The r…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Attovia, Braveheart Bio, and Vogenx aim to raise over $500M through combined IPOs
    Attovia Therapeutics, Braveheart Bio and Vogenx have each filed IPO paperwork, setting price ranges that together target more than $500 million in gross proceeds from public investors. Braveheart…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • EFPIA urges EU lawmakers to further cut clinical trial approval timelines under Biotech Act
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) has asked EU legislators to go beyond the modest reductions in clinical trial approval times that are currently being c…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Legend Biotech CEO Ying Huang resigns abruptly, board taps interim leader
    Legend Biotech announced that its chief executive, Dr. Ying Huang, has stepped down unexpectedly, leaving the role vacant. Huang, who moved from chief financial officer to CEO in 2020 after a cust…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Biogen beats revenue expectations, lifts investor confidence with 3% sales rise
    Biogen reported $2.7 billion in revenue for the April‑June quarter, a 3% increase year over year, surpassing analysts' consensus estimate of $2.5 billion. Adjusted earnings per share came in at $3.…
    BioPharma Dive · 1mo agoEarningsPositive↗ source
  • FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy
    A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ source
  • FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%
    Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • MapLight Therapeutics' mid-stage schizophrenia trial shows modest improvement but shares plunge two-thirds
    MapLight Therapeutics announced that its experimental schizophrenia drug met its primary endpoint in a mid-stage study, delivering an average 4.5‑point reduction on the PANSS symptom scale after fi…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Novo Nordisk loses bid to dismiss lawsuit over CagriSema trial readout
    U.S. District Judge Robert Kirsch in New Jersey refused to dismiss most of the securities lawsuit filed by investors after Novo Nordisk’s CagriSema readout. While the judge found the plaintiffs’ cl…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Processa Pharma acquires Vidya Therapeutics, gaining oral BTK inhibitor VT-7208
    Processa Pharmaceuticals announced an all‑stock acquisition of Vidya Therapeutics, a Florida biotech developing an oral BTK inhibitor called VT‑7208. VT‑7208 is being positioned as a next‑generati…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Caldera Therapeutics completes reverse merger with Synlogic, secures $278 million financing
    Caldera Therapeutics, a Massachusetts biotech founded last year, announced a reverse merger with Nasdaq-listed Synlogic, giving it a public listing. The transaction includes a $278 million financi…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Caldera Therapeutics merges with Synlogic, secures $278M to advance inflammation drug
    Caldera Therapeutics, a startup founded seven months ago with $112.5 million of venture funding, announced a merger with Synlogic, a company that previously went public via a reverse merger. The a…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Nanoparticle-loaded chemotherapy crosses blood-brain barrier in mice after glioblastoma surgery, study shows
    Researchers at the University of Manchester have demonstrated that a standard chemotherapy drug can reach the brain when packaged in liposome nanoparticles and given shortly after tumor removal in…
    Fierce Biotech · 1mo agoPositive↗ source
  • Biogen CEO says company will pause new acquisitions and focus on developing existing pipeline
    Biogen's chief executive Christopher Viehbacher told analysts during the second-quarter earnings call that the company will slow its merger and acquisition activity for the foreseeable future. Aft…
    Fierce Biotech · 1mo agoDealNeutral↗ source