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592 stories matching this filter · ← front page

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  • FDA urges Amgen to withdraw Tavneos after alleging data manipulation by former developer
    The FDA has sent a formal letter to Amgen recommending that the company pull its drug Tavneos from the market. The agency says new information shows the original approval filings from ChemoCentryx…
    BioPharma Dive · 5mo agoRegulatoryNegative↗ source
  • Eli Lilly partners with AI startup Profluent to develop next-generation gene editors
    Eli Lilly announced a collaboration with AI-focused biotech Profluent to create advanced gene-editing tools that could insert whole genes into patients. The partnership is intended to move beyond…
    STAT · 5mo agoDealPositive↗ source
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  • BridgeBio's heart drug Attruby exceeds sales expectations, shifting investor outlook
    BridgeBio prepared to sell its heart drug Attruby on its own, prompting skepticism from investors and analysts who doubted the company could compete with larger rivals. The drug far outperformed f…
    BioPharma Dive · 5mo agoPositive↗ source
  • FDA launches AI-driven pilot to review trial data in real time, aiming to speed clinical studies
    Washington officials said the Food and Drug Administration is starting a new program to speed clinical trials by reviewing data as it is generated. The first pilots will use real-time data from tr…
    STAT · 5mo agoRegulatoryPositive↗ source
  • FDA commissioner touts real-time trial monitoring to cut drug development dead time
    The Food and Drug Administration announced a new approach that will let regulators view clinical trial endpoints as they happen, using cloud‑based data streams. The move targets the long delays th…
    STAT · 5mo agoRegulatoryPositive↗ source
  • STAT+: Boehringer’s obesity drug shows 16.6% weight loss; more data needed
    Eli Lilly's deal with Profluent, Erasca's RAS-targeting cancer pill, and more biotech news today
    STAT · 5mo agoDealNeutral↗ source
  • Former NIAID adviser David Morens indicted for hiding emails and falsifying records
    David Morens, a former senior adviser at the National Institute of Allergy and Infectious Diseases, was indicted on Tuesday for allegedly concealing emails and providing false responses to Freedom…
    STAT · 5mo agoRegulatoryNegative↗ source
  • New U.S. hepatitis B vaccine policy targeting only at-risk newborns could raise infant infections and costs, studies warn
    A new U.S. recommendation limits the birth‑dose hepatitis B vaccine to infants who are judged to be at risk of neonatal infection, rather than offering it universally to all newborns. One study co…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Oruka’s experimental psoriasis drug achieves near-complete skin clearance in Phase 2 trial
    Oruka Therapeutics reported that its experimental IL-23 inhibitor ORKA-001 cleared the skin of 40 of 63 patients (about 63%) in a Phase 2 study, achieving a PASI 100 response at 16 weeks. A further…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
  • Erasca reports early trial shows tumor shrinkage in 40% of pancreatic and 62% of lung cancer patients
    Erasca announced that its experimental RAS-targeting oral drug, ERAS-0015, produced tumor reductions in a portion of patients with advanced pancreatic cancer and advanced non-small cell lung cancer…
    STAT · 5mo agoPositive readoutPositive↗ source
  • Experts say Covid risk has faded, but boosters still advised for vulnerable groups
    Health journalist Helen Branswell reflects on how Covid-19, once the dominant global threat, has receded in public consciousness. Six years after the 2020 lockdowns, mask-wearing and social distanc…
    STAT · 5mo agoNeutral↗ source
  • Avalyn Pharma targets $182M IPO as WHO prequalifies Novartis malaria drug
    Avalyn Pharma announced plans for an initial public offering that could raise about $182 million in net proceeds. The company is developing inhaled formulations of drugs already approved for pulmon…
    Endpoints · 6mo agoDealNeutral↗ source
  • Sanofi beats Q1 sales forecasts, driven by strong Dupixent demand
    Sanofi reported first‑quarter results that exceeded Wall Street expectations, with net sales rising 6.2% to €10.5 billion (about $12.3 billion).\n\nThe growth was led by Dupixent, the anti‑inflamma…
    BioPharma Dive · 6mo agoEarningsPositive↗ source
  • Revolution Medicines' early-stage pancreatic cancer drug shows tumor control in half of patients
    Revolution Medicines reported that its experimental therapy daraxonrasib helped control tumors in at least half of patients with early-stage pancreatic cancer, whether given alone or with chemother…
    BioPharma Dive · 6mo agoPositive readoutPositive↗ source
  • Merck commits up to $1 billion to Google Cloud partnership to accelerate AI across its operations
    Merck announced a multiyear partnership with Google Cloud, investing up to $1 billion to embed AI tools throughout its research, development, manufacturing, commercial and corporate functions. The…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • Biotech layoff tracker 2026 shows Clinuvel cuts 20% staff, Novartis sheds 322 US jobs
    Fierce Biotech released its fifth annual layoff tracker for 2026, noting that workforce reductions continue to rise in the sector after a year of increasing cuts. The July update lists two compani…
    Fierce Biotech · 10mo agoLayoffsNegative↗ source
  • Biotech fundraising tracker reports $70M Series C for Ratio Therapeutics and $130M Series B for Crystalys Therapeutics
    The Fierce Biotech Fundraising Tracker continues to log only large venture capital rounds, focusing on deals of $50 million or more. Ratio Therapeutics secured a $70 million Series C, backed by in…
    Fierce Biotech · 10mo agoDealNeutral↗ source