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873 stories matching this filter · ← front page

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STAT1776Endpoints1385Fierce Biotech703BioSpace695BioPharma Dive523raps231onclive165fda recalls111
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allOncology12299Rare Disease3204Immunology2860Cardiology2726Hematology2177Pulmonology2138Vaccines1794
  • 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 · 2mo 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 · 2mo agoNegative readoutNegative↗ source
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fda medwatch111
globenewswire health73
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Psychiatry & CNS1204
Ophthalmology1050
Endocrinology & Metabolism775
Pain775
Nephrology759
  • 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 · 2mo agoNegative↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoPositive readoutPositive↗ 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 · 2mo 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 · 2mo agoRegulatoryNeutral↗ 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 · 2mo agoCRLNeutral↗ source
  • Northwest Naturals recalls frozen cat and dog chicken diets over possible Salmonella and Listeria contamination
    Northwest Naturals of Portland, Oregon announced a voluntary recall of two frozen pet food products after detecting possible bacterial contamination. The recall includes 53 cases (1,272 lb) of fro…
    fda recalls · 2mo agoCRLNegative↗ source
  • FDA approves Mimrylo, first hepcidin-mimicking drug for polycythemia vera
    The U.S. Food and Drug Administration announced approval of Mimrylo (rusfertide) for adult patients with polycythemia vera, a rare blood disorder that causes excess red blood cells. The drug mimic…
    fda press · 2mo agoApprovalPositive↗ source
  • AusperBio secures $120 million Series C to push hepatitis B antisense therapy into Phase 3
    AusperBio Therapeutics announced it has closed a $120 million Series C financing round aimed at moving its hepatitis B antisense oligonucleotide candidate toward late‑stage trials and eventual mark…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Roche pays $190 million for rights to Hanmi's UCN2 analog targeting obesity with muscle-preserving effects
    Roche's Genentech unit has agreed to pay $190 million upfront for rights to HM17321, a urocortin‑2 analog developed by South Korea’s Hanmi Pharmaceutical, covering markets outside South Korea. The…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Genentech pays $45M upfront to DualityBio for ADC platform targeting resistant cancers
    Genentech has agreed to pay DualityBio $45 million upfront for rights to its antibody‑drug conjugate (ADC) technology, with the agreement offering more than $1 billion in potential milestone paymen…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • BioNTech-Genentech halts colorectal cancer vaccine trial after higher death rate in vaccine arm
    BioNTech and Genentech stopped a phase 2 trial of their personalized mRNA vaccine BNT122 in patients with stage 2 or 3 colorectal cancer after an independent data safety monitoring board found more…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • Everything Sprouts expands voluntary recall of Robust Radish Sprout Mix over possible E. coli and Salmonella contamination
    Everything Sprouts, LLC announced an expansion of its voluntary recall to include additional lots of its 5‑oz Robust Radish Sprout Mix after identifying a potential contamination risk. The company…
    fda recalls · 2mo agoRegulatoryNegative↗ source
  • Teva named stalking horse bidder to acquire BioXcel's neuroscience assets for $57.5 million
    BioXcel Therapeutics, a Connecticut biotech focused on neuroscience, filed for Chapter 11 bankruptcy after running out of cash to fund operations through August. In the filing, the company selecte…
    Fierce Biotech · 2mo agoDealNeutral↗ source
  • Panorama Produce recalls 302 boxes of mangoes over possible Salmonella contamination
    Panorama Produce announced a recall of 302 boxes of size 9 mangoes because they may be contaminated with Salmonella. The recalled mangoes were distributed from August 10 to August 21, 2026 to Conn…
    fda recalls · 2mo agoRegulatoryNegative↗ source
  • CEPI pledges up to $16.5M to advance Egyptian biotech's Ebola vaccine candidate
    CEPI has committed up to $16.5 million to help bring Minapharm’s Bundibugyo Ebola vaccine candidate into clinical testing. The funding will support preclinical work and an early-stage human trial…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • FDA greenlights first oral therapy for adult dermatomyositis
    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis. Dermatomyositis is a rare autoimmune condition that attacks muscle…
    fda press · 2mo agoApprovalPositive↗ source
  • Roche receives expanded FDA clearance for HER2 diagnostic tests linked to Jazz’s Ziihera cancer drug
    Roche announced that the U.S. Food and Drug Administration has broadened the clearance for two of its HER2 diagnostic assays, allowing their use in metastatic gastroesophageal adenocarcinoma. The…
    Fierce Biotech · 2mo agoCRLPositive↗ source
  • FDA grants emergency use authorization for generic Bimectin injection to prevent screwworm in cattle
    The U.S. Food and Drug Administration announced an Emergency Use Authorization for the generic ivermectin product Bimectin injection, allowing its use to prevent New World screwworm infestations in…
    fda press · 2mo agoRegulatoryPositive↗ source