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734 stories matching this filter · ← front page

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  • Frutas y Hortalizas del Sur expands recall to include Great Value organic triple berry blend over possible E. coli O145 contamination
    On September 2, 2026, Frutas y Hortalizas del Sur S.A. announced that it is expanding the recall it issued on July 3, 2026 for frozen organic IQF blueberries. The expansion adds one lot of Great V…
    fda recalls · 9d agoCRLNegative↗ source
  • Moderna and Merck's mRNA cancer vaccine extends survival in phase 3 melanoma trial
    Merck and Moderna reported that their personalized mRNA cancer vaccine improved patient outcomes in a late-stage study. The phase 3 INTerpath-001 trial enrolled 1,137 patients who had surgery to r…
    Fierce Biotech · 10d agoPositive readoutPositive
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Infectious Disease456
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  • Roche signs $1.53 billion licensing deal with Simcere for preclinical B-cell antibody
    Roche announced a licensing agreement with China's Simcere Zaiming, paying $75 million upfront and potentially up to $1.53 billion in total, for worldwide rights to a preclinical trispecific antibo…
    Fierce Biotech · 10d agoDealPositive↗ source
  • GSK's mRNA flu vaccine shows stronger immune response than standard shots in phase 2, prompting phase 3 launch
    GSK reported that its experimental mRNA seasonal influenza vaccine generated higher immune responses than both standard and high-dose flu shots in a phase-2 study involving nearly 1,000 adults. Th…
    Fierce Biotech · 11d agoPositive readoutPositive↗ source
  • Medtronic recalls Bravo CF reflux monitoring capsule after 184 serious injuries reported
    Medtronic has issued a recall of its Bravo CF esophageal pH monitoring capsule, a wireless device used to assess acid reflux. The recall follows an FDA early alert after the company identified a pr…
    Fierce Biotech · 11d agoCRLNegative↗ source
  • Boston Scientific stops sales of Imager II catheters after tip defect linked to two injuries
    Boston Scientific issued a letter on August 24 advising customers to remove all Imager II angiographic catheters from use or sale after discovering a manufacturing problem. The problem involves re…
    Fierce Biotech · 11d agoCRLNegative↗ source
  • Arsenal Biosciences cuts 99 jobs as it pivots to in-vivo CAR-T therapy
    Arsenal Biosciences announced a major restructuring, laying off 99 employees, which represents the majority of its workforce across all teams and locations. The company is ending development of it…
    Fierce Biotech · 10d agoLayoffsNegative↗ source
  • Alumis' lupus trial misses endpoints, but company eyes phase 3 in IFNGS‑high subgroup
    Alumis reported that its phase 2b study of the TYK2 inhibitor envudeucitinib failed to meet both the primary and secondary efficacy endpoints in patients with moderate to severe systemic lupus eryt…
    Fierce Biotech · 11d agoNegative readoutNegative↗ source
  • Novocure cyberattack exposes data of over 1,400 U.S. patients and staff
    Novocure disclosed a cyberattack in an SEC filing, saying unauthorized access to some information systems was discovered in mid‑August. The breach exposed internal patient ID numbers for more than…
    Fierce Biotech · 11d agoNegative↗ source
  • FDA releases draft guidance on evaluating drug behavior in patients with liver impairment
    The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…
    raps · 11d agoRegulatoryNeutral↗ source
  • FDA urges validation of digital health endpoints and clear missing-data plans
    FDA officials highlighted key practices for sponsors using digitally derived endpoints from digital health technologies. They said endpoints must be validated for the specific patient population t…
    raps · 11d agoRegulatoryNeutral↗ source
  • Trump unveils pricing agreements with midsize biotech firms; Novartis halts CAR-T trial after patient deaths
    The White House announced that President Trump has struck new pricing agreements with a group of midsize biotechnology companies, aiming to adjust drug costs. Novartis disclosed that it is pausing…
    raps · 11d agoDealNeutral↗ source
  • Absci CEO envisions AI-driven, consumer-focused drug platform, eyeing hair loss, endometriosis and future GLP-1 combos
    Absci, an AI‑focused biotech founded about 15 years ago in Vancouver, Washington, is led by CEO Sean McClain, who likens his ambition for the company to creating the Apple of biotech. The surge in…
    Fierce Biotech · 10d agoPositive↗ source
  • Eli Lilly to acquire Merida Biosciences for up to $2.88 billion, adding autoimmune antibody-degrading pipeline
    Eli Lilly announced a transaction to purchase Merida Biosciences for up to $2.875 billion, combining an upfront cash payment with future milestone payments. Merida, which emerged from stealth last…
    Fierce Biotech · 12d agoDealPositive↗ source
  • FDA clears Protagonist-Takeda therapy for rare blood cancer as Lilly moves to buy Merida for up to $2.88 billion
    The U.S. Food and Drug Administration has granted approval to a collaborative therapy from Protagonist and Takeda aimed at treating a rare form of blood cancer. This regulatory decision adds a new…
    raps · 12d agoDealPositive↗ source
  • Novartis and Bristol Myers pause multiple autoimmune CAR-T trials after serious immune adverse events
    Novartis and Bristol Myers Squibb announced a temporary halt to several CAR-T cell therapy trials targeting autoimmune diseases. The pause involves Novartis’s autologous CD19 CAR-T candidate rapca…
    Fierce Biotech · 11d agoRegulatoryNegative↗ source
  • Analysts see opportunity for Alnylam’s RNAi therapy after AstraZeneca/Ionis ATTR-CM trial fails
    AstraZeneca and its partner Ionis reported a disappointing Phase 3 result for the antisense drug Wainua in transthyretin amyloid cardiomyopathy (ATTR-CM). The unexpected outcome was a focal point o…
    Fierce Biotech · 11d agoNegative readoutNeutral↗ source
  • Electra Therapeutics files for Nasdaq IPO to fund phase 2/3 immunology and cancer programs
    Electra Therapeutics, based in South San Francisco, announced it has filed a registration statement to list its shares on the Nasdaq Global Select Market under the ticker ETRA. The company says th…
    Fierce Biotech · 11d agoDealPositive↗ source
  • AstraZeneca's oral relaxin agonist shows positive phase 2b results in chronic heart failure
    AstraZeneca presented phase 2b data from its Luminara trial at the European Society of Cardiology Congress in Munich. The study evaluated the oral relaxin agonist AZD5462 in patients with chronic h…
    Fierce Biotech · 11d agoPositive readoutPositive↗ source
  • Experts urge FDA to boost transparency of complete response letters and refine master protocol guidance
    A recent paper in the Journal of Law and the Biosciences outlines ways the FDA could better disclose complete response letters to the public, aiming to increase transparency for stakeholders. Indu…
    raps · 12d agoRegulatoryNeutral↗ source
  • Natera partners with Angiex to evaluate Signatera blood test in AGX101 cancer trial
    Natera announced a collaboration with biotech Angiex to assess its Signatera circulating tumor DNA blood test in the context of Angiex’s early‑stage clinical trial of AGX101. Angiex, based in Camb…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Crystal Temptations Issues Allergy Alert on Undeclared Milk in Chocolatey Eyeballs
    Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run th…
    fda recalls · 11d agoRegulatoryNeutral↗ source
  • Industry and patient groups urge FDA to revise master protocol guidance
    Industry groups and patient advocacy organizations have written to the U.S. Food and Drug Administration asking for several revisions to its recently updated draft guidance on master protocols for…
    raps · 12d agoRegulatoryNeutral↗ source
  • India streamlines regulations for outsourced medical device sterilization
    The Indian government announced a simplification of the regulatory framework governing outsourced sterilization of medical devices. The move is part of a broader effort to make it easier for busine…
    raps · 12d agoRegulatoryPositive↗ source
  • Kofinas Olive Oil voluntarily recalls garlic-infused extra virgin olive oil over unapproved essential oil
    LMSI LLC/Kofinas Olive Oil announced a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil because it contains a garlic essential oil not approved for culinary use. The pro…
    fda recalls · 11d agoCRLNeutral↗ source