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136 stories matching this filter · ← front page

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  • Capricor plans FDA amendment after advisory committee rejects cardiomyopathy endpoint, stock jumps
    Capricor Therapeutics received a negative vote from an FDA advisory committee on the efficacy of its cell therapy, deramiocel, for treating cardiomyopathy in Duchenne muscular dystrophy. The nine‑t…
    Fierce Biotech · 10h agoRegulatoryPositive↗ source
  • Jazz Pharmaceuticals to acquire Actio Biosciences in deal worth over $1.3 billion
    Jazz Pharmaceuticals announced an agreement to purchase Actio Biosciences, a San Diego biotech focused on genetic epilepsies. The transaction could total just over $1.3 billion, with $820 million…
    BioPharma Dive · 4d agoDealPositive↗ source
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Infectious Disease323
  • Jazz Pharma to acquire Actio Biosciences for $820M, adding KCNT1+ epilepsy drug to its pipeline
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences for an upfront payment of $820 million, expanding its portfolio of epilepsy medicines. The deal brings Actio’s lead candidate, ABS…
    Fierce Biotech · 4d agoDealPositive↗ source
  • FDA approves Takeda’s orexin-2 drug Orzeyful for narcolepsy type 1
    The U.S. Food and Drug Administration has approved Takeda Pharmaceutical's new sleep medication, Orzeyful, marking the first product in the emerging orexin‑2 drug class. Orzeyful works by amplifyi…
    BioPharma Dive · 8d agoApprovalPositive↗ source
  • BioNTech appoints former Sobi chief Guido Oelkers as new CEO
    BioNTech has filled its long-vacant chief executive position after a six-month search. The board selected Guido Oelkers, Ph.D., who most recently led Swedish pharmaceutical company Sobi. At Sobi,…
    Fierce Biotech · 8d agoNeutral↗ source
  • BioVie’s Parkinson drug data prompts 50% stock drop as company shifts to composite endpoint
    BioVie announced phase 2 results for its experimental Parkinson’s therapy bezisterim, saying the data suggest a meaningful advance in treating the disease. Investors reacted sharply, wiping out ro…
    Fierce Biotech · 8d agoNegative readoutNegative↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda recalls · 10d agoCRLNegative↗ source
  • Curium to acquire Lantheus in deal valued up to $8 billion
    Curium announced it will purchase all outstanding shares of Lantheus for $102.50 cash per share, with potential additional $12 per share via contingent value rights linked to sales milestones in pr…
    Fierce Biotech · 11d agoDealNeutral↗ source
  • Supernus and Individor to merge, creating $2 billion brain-drug company
    Supernus and Individor announced a merger that will combine their portfolios of neurological medicines. The two firms together generated about $2 billion in revenue in 2025 from roughly a dozen CN…
    BioPharma Dive · 11d agoDealPositive↗ source
  • Neurologist Who Diagnoses ALS Patients Receives Own Diagnosis, Reflects on Impact of Disability
    Dr. Christopher Campos, a neurologist and assistant professor at UC Davis Health, disclosed that he was diagnosed with amyotrophic lateral sclerosis (ALS) in 2025 after a decade of delivering the s…
    STAT · 11d agoNegative↗ 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 · 15d agoEarningsNeutral↗ 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 · 16d agoDealNeutral↗ source
  • Dementia finally shows a viable business model, AAIC2026 highlights economic shift
    At the Alzheimer’s Association International Conference in London this year, the author observed that dementia now appears to have a clear business model, a shift from earlier meetings where commer…
    STAT · 17d agoPositive↗ source
  • MapLight shares tumble over 60% after mixed Phase 2 schizophrenia trial results
    MapLight Therapeutics reported mixed outcomes from its Phase 2 Zephyr trial of the experimental schizophrenia drug ML-007C-MA, causing its stock to fall sharply. The trial enrolled 307 patients wi…
    Fierce Biotech · 18d agoNegative readoutNegative↗ source
  • Biotech confidence surges in 2026 as China leads growth and deal activity spikes
    Industry observers noted a marked shift in tone at two major 2026 biotech gatherings – the DIA China meeting in Shanghai and the BIO International Convention in San Diego – where participants expre…
    BioPharma Dive · 18d agoPositive↗ source
  • Labcorp unveils direct-to-consumer genetic health panel covering 163 genes and 100+ conditions
    Labcorp announced the launch of a new direct-to-consumer test called the Marker by Labcorp Genetic Health Panel. The panel examines 163 genes to assess risk for more than 100 hereditary conditions…
    Fierce Biotech · 18d agoPositive↗ source
  • Clinuvel to relocate HQ to US and cut up to 20% of staff
    Clinuvel Pharmaceuticals, an Australian biotech, announced it will move its corporate headquarters to the United States starting Jan 1, 2027. The company said the shift is aimed at attracting U.S.…
    Fierce Biotech · 22d agoLayoffsNegative↗ source
  • Jupiter Neurosciences signs $100M deal for U.S. rights to PharmAla's MDMA therapy ALA-002
    Jupiter Neurosciences announced a licensing agreement with Canadian biotech PharmAla Biotech to obtain U.S. rights to an MDMA‑based drug, ALA‑002, aimed at treating neuropsychiatric conditions. Th…
    Fierce Biotech · 24d agoDealPositive↗ source
  • Axiom Biosciences to launch IPO on Hong Kong exchange before Nasdaq co‑listing
    San Diego‑based Axiom Biosciences announced plans to go public with a primary listing on the Hong Kong Stock Exchange, followed later by a Nasdaq co‑listing, a structure it says is a first for a U.…
    Fierce Biotech · 25d agoDealPositive↗ source
  • Biotronik Neuro acquires Soin Neuroscience spinal cord stimulation patent portfolio to boost next-gen pain therapy
    Biotronik Neuro, the neuromodulation arm of Berlin-based medtech firm Biotronik, announced it has purchased a collection of spinal cord stimulation patents from Ohio-based Soin Neuroscience. The a…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Why Axiom hopes it’s ‘solved 2 major potholes’ that have hurt other stem cell biotechs
    When Axiom's stem cell therapy demonstrated a 0% mortality rate over two years in potentially fatal newborn neurological diseases this week, the biotech's leadership saw a broader validation for th…
    Fierce Biotech · 1mo ago↗ source
  • Bryan Johnson’s chronic disease is notoriously difficult to diagnose
    Why longevity entrepreneur Bryan Johnson’s chronic disease is notoriously difficult to diagnose.
    STAT · 1mo ago↗ source
  • Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal
    An arbitration panel ruled Prime didn’t breach a deal with Beam by developing a rare disease treatment. Elsewhere, European regulators are using a pancreatic cancer drug to test a new framework for…
    BioPharma Dive · 1mo ago↗ source
  • Opinion: STAT+: What’s the right role for AI in dementia care?
    Three tricky questions about using AI in dementia care.
    STAT · 1mo ago↗ source
  • Gene editing developer Scribe plots an IPO
    The California drugmaker, which has collaborations in place with Biogen, Sanofi and Eli Lilly, could be the 14th biotech to go public in 2026.
    BioPharma Dive · 1mo ago↗ source