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2,252 stories matching this filter · ← front page

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  • Braveheart Bio raises $382.5M in IPO to fund phase 3 trial of cardiac drug
    Braveheart Bio, a San Francisco biotech, completed an IPO that raised $382.5 million, exceeding its original target. The company increased the share count to 21.2 million and set the price at $18…
    Fierce Biotech · 5d agoDealPositive↗ source
  • FDA approves Moderna flu vaccine
    The U.S. Food and Drug Administration granted approval to Moderna's seasonal flu vaccine, adding another product to the company's portfolio. The approval was announced late Wednesday, after a repo…
    Endpoints · 5d agoApprovalPositive↗ source
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  • Revolution Medicines readies launch of experimental pancreatic cancer drug daraxonrasib as approval decision pending
    Revolution Medicines executives say they are preparing to launch daraxonrasib, an experimental therapy for metastatic pancreatic cancer. The drug is currently awaiting regulatory decisions in the…
    Endpoints · 5d agoNeutral↗ source
  • FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelines
    FDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…
    raps · 5d agoRegulatoryNeutral↗ source
  • BioVie shares plunge as Parkinson’s trial results lack primary motor data
    BioVie reported results of its Phase 2 SUNRISE-PD study in early‑stage Parkinson’s disease. The double‑blind, placebo‑controlled trial enrolled 57 patients who had not yet received carbidopa/levodo…
    BioSpace · 5d agoNegative readoutNegative↗ source
  • Sarepta delays Elevidys study readout while Emergent cuts 90 jobs
    Sarepta Therapeutics told investors that the readout for its non‑ambulatory Elevidys trial will not be available by the end of the year as previously expected. The company indicated the delay durin…
    Endpoints · 5d agoNegative readoutNegative↗ source
  • Podcast explores emerging rapid‑acting and psychedelic therapies for treatment‑resistant depression
    In a recent episode of BioSpace’s Denatured podcast, host Jennifer C. Smith‑Parker talks with Hans Eriksson, chief medical officer of FundaMental Pharma, and Steve Levine, chief patient officer at…
    BioSpace · 5d agoPositive↗ source
  • Braveheart Bio raises $383 million in Nasdaq IPO to advance Hengrui cardiovascular drug to Phase 3
    Braveheart Bio, a U.S. biotech spun out of China’s Hengrui Pharmaceuticals, completed an initial public offering on the Nasdaq. The offering generated about $383 million in gross proceeds, providi…
    Endpoints · 5d agoDealPositive↗ source
  • Experts call for independent 9/11‑style commission to review U.S. Covid response
    In an opinion piece, IDSA President Ronald Nahass argues that the United States should create a nonpartisan, 9/11 Commission‑style body to examine the Covid‑19 response. He says such an inquiry wou…
    STAT · 5d agoNeutral↗ source
  • Tiziana Life Sciences CEO Ivor Elrifi buys 321,423 shares, raising his stake to 4.79 million
    Tiziana Life Sciences announced that its chief executive, Ivor Elrifi, purchased 321,423 common shares of the company on NASDAQ at $1.00 per share. The transaction brings Elrifi’s total ownership…
    globenewswire health · 5d agoDealPositive↗ source
  • Novo Nordisk reports board and executive share transactions under EU market abuse rules
    On August 6, 2026 Novo Nordisk issued a company announcement detailing share transactions made by members of its board, senior executives and their close associates in line with Article 19 of EU Re…
    globenewswire health · 5d agoRegulatoryNeutral↗ source
  • Context Therapeutics drops CT-95 bispecific T-cell engager to stretch cash runway to 2027
    Context Therapeutics announced it is halting development of its bispecific T-cell engager CT-95. The company acquired CT-95 in 2024 for $3.7 million and began dosing patients in a phase 1 trial in…
    Fierce Biotech · 5d agoNegative↗ source
  • Actimed regains full rights to S-oxprenolol, ends $126 million Faraday licensing deal
    Actimed Therapeutics announced it has reclaimed all worldwide rights to its experimental wasting disease drug S-oxprenolol, terminating the licensing agreement it had with Faraday Pharmaceuticals.…
    Fierce Biotech · 5d agoDealNeutral↗ source
  • Tiziana Life Sciences CEO Ivor Elrifi boosts stake, buying 321,423 shares at $1 each
    Tiziana Life Sciences announced that its chief executive officer, Ivor Elrifi, purchased 321,423 common shares of the company on NASDAQ at $1.00 per share. The purchase raises his total holding to…
    globenewswire health · 5d agoDealPositive↗ source
  • Vistagen's anxiety nasal spray fails to outperform placebo in phase 2 trial
    Vistagen Therapeutics reported that its experimental nasal spray fasedienol did not show a statistically significant advantage over placebo in a phase 2 study of social anxiety disorder. The trial…
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • PacBio appoints COO Mark Van Oene as new CEO after Christian Henry steps down
    PacBio announced that its chief operating officer, Mark Van Oene, will become president and chief executive officer effective Aug. 5 and will join the company's board. Van Oene, who joined PacBio…
    Fierce Biotech · 5d agoNeutral↗ source
  • Choosing Between CROs and Biotechs: How Company Size Shapes the Fit
    While biotechs and contract research organizations each have strengths, the article notes that the right choice depends on a company’s specific situation. Ali Pashazadeh, founder and CEO of Treehi…
    BioSpace · 5d agoNeutral↗ source
  • BioSpace lists top 12 biopharma employers hiring in July 2026
    BioSpace released a list of the twelve biopharma firms with the most job postings in July 2026. The list includes AbbVie, Regeneron, Amgen, Eli Lilly, Sanofi, Novo Nordisk, Moderna, Insmed, Freder…
    BioSpace · 5d agoNeutral↗ source
  • EMA launches consultation to streamline nonclinical development for life-threatening diseases
    EMA announced a public consultation on proposals to accelerate the nonclinical phase of drug development for diseases that are severely debilitating or life‑threatening. The agency aims to reduce…
    raps · 5d agoRegulatoryNeutral↗ source
  • Medicare advances ACCESS pilot but leaves patients unaware of participating providers
    STAT's Health Tech newsletter reports that Medicare is promoting its ACCESS chronic‑care pilot, yet patients cannot see which providers are offering the program. A one‑month progress check highlig…
    STAT · 5d agoRegulatoryNeutral↗ source
  • Merck KGaA to receive up to €40 million in US tariff refunds for life science business through 2026
    Merck KGaA announced that it expects to receive tariff refunds for its life‑science division after a US Supreme Court ruling. The company estimates the refunds will total roughly €40 million and w…
    Endpoints · 5d agoRegulatoryPositive↗ source
  • Novo Nordisk board members disclose share vesting transactions
    Novo Nordisk issued a regulatory announcement on 6 August 2026 detailing share transactions by its board members, executives and related persons, as required by EU market abuse regulation. The fil…
    globenewswire health · 5d agoRegulatoryNeutral↗ source
  • Centene reports strong enrollment growth but modest scale for its ICHRA offering
    Centene's chief executive Sarah London said the company's individual coverage health reimbursement arrangement (ICHRA) business is experiencing a strong enrollment growth rate, though the total num…
    Endpoints · 5d agoEarningsPositive↗ source
  • US moves to shut Kentucky organ donation nonprofit over safety failures
    The U.S. Health Secretary announced that the federal government will begin the process to decertify Network for Hope, a Kentucky-based organ procurement organization, after allegations of safety la…
    STAT · 5d agoRegulatoryNegative↗ source
  • Senate committee votes to hold Dr. Fauci in contempt over Covid testimony
    A Senate committee voted along party lines to hold former health official Dr. Anthony Fauci in contempt of Congress after he refused to answer questions about his role in the Covid 19 pandemic resp…
    STAT · 5d agoRegulatoryNegative↗ source