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  • Biopharma job postings rise 15% in Q2 as layoffs fall and M&A activity picks up
    The Q2 2026 BioSpace report shows a strengthening biopharma job market, with more openings and fewer layoffs compared with the prior year. Job postings on BioSpace were up 15% year-over-year and 1…
    BioSpace · 19d agoPositive↗ source
  • Intellia identifies HLA allele linked to severe liver enzyme spikes in ATTR gene therapy
    In November 2025, a patient died after receiving Intellia Therapeutics' investigational gene silencer for transthyretin amyloidosis, prompting a safety review of the company’s ATTR gene therapy pro…
    BioSpace · 19d agoRegulatoryNeutral↗ source
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fda recalls54
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Psychiatry & CNS757
Ophthalmology455
Pain424
Endocrinology & Metabolism402
Infectious Disease380
  • Active shooter incident forces CDC staff to shelter in place, highlighting ongoing threats to public health workers
    On August 8, 2025, the author was working in an office at the Centers for Disease Control and Prevention when a series of loud bangs sounded outside. A laboratory director reported that a neighbori…
    STAT · 19d agoNegative↗ source
  • FDA outlines inspection overhaul, proposes IND reforms, and greenlights a disputed cancer therapy
    FDA officials announced a plan to restructure the agency’s inspectional operations, aiming to make inspections more efficient and focused. The proposed changes include consolidating regional office…
    raps · 19d agoRegulatoryNeutral↗ source
  • NIH to restrict Pathways to Independence grants to U.S. citizens and permanent residents
    The National Institutes of Health announced plans to limit eligibility for its “Pathways to Independence” award to U.S. citizens, permanent residents, and non‑citizen nationals. The change would ba…
    STAT · 19d agoRegulatoryNegative↗ source
  • EMA releases updated guidance on drug shortage prevention plans
    The European Medicines Agency has published a revised guideline aimed at helping marketing authorisation holders develop and keep drug shortage prevention plans for their products. The new guidanc…
    raps · 19d agoRegulatoryNeutral↗ source
  • Eli Lilly and Novo Nordisk win dismissal of antitrust suit by compound pharmacy
    A federal judge has thrown out an antitrust lawsuit filed by a compound pharmacy against Eli Lilly and Novo Nordisk. The decision clears the two companies of the alleged wrongdoing and removes a le…
    STAT · 19d agoRegulatoryNeutral↗ source
  • Boston-born biotech founder Felix Wong launches AI-driven startup in California
    Felix Wong grew up near Boston, earned two degrees at Harvard and completed a post-doc at MIT before launching his biotech company in California. His startup applies artificial intelligence to ide…
    STAT · 19d agoNeutral↗ source
  • Third gender-affirming clinic settles with DOJ as Senate moves to hold Fauci in contempt
    A third clinic that provides gender-affirming services reached a settlement with the Department of Justice, ending a federal investigation into alleged civil-rights violations. The agreement inclu…
    STAT · 19d agoRegulatoryNeutral↗ source
  • Vistagen’s anxiety nasal spray fails to outperform placebo in Phase 2 study
    Vistagen reported results of its Phase 2 trial of the investigational nasal spray fasedienol for social anxiety disorder. The study enrolled 61 patients who were randomly assigned to receive a sin…
    BioSpace · 19d agoNegative readoutNegative↗ source
  • AI will further erode physician autonomy, says former surgeon
    Frances Mei Hardin, a former ENT surgeon and consultant, argues that artificial intelligence will not increase doctors' independence but will further reduce it. She points out that the same top-do…
    STAT · 19d agoNegative↗ source
  • Senior staff purchase company shares, filing 16/2026 shows insider buying
    The company released a corporate announcement stating that several senior employees have bought shares of the firm. The filing, identified as 16/2026, does not provide details on the number of sha…
    globenewswire health · 19d agoNeutral↗ source
  • EpilepsyGTx appoints Teresa Nunes as chief medical officer
    EpilepsyGTx announced the hiring of Teresa Nunes to serve as its new chief medical officer. Nunes moves to the company after holding the same position at Allucent. The appointment is part of a bro…
    STAT · 19d agoPositive↗ source
  • Senate hearings blame China, not Fauci, for Covid-19 origin delays
    A Senate committee recently held a hearing on the origins of Covid-19 and concluded that Dr. Anthony Fauci was in contempt of Congress after invoking his Fifth Amendment rights. The author, a prof…
    STAT · 19d agoNegative↗ source
  • Company issues corporate announcement on senior employee transaction
    The company released a corporate announcement identified as item 18/2026. The notice indicates that a transaction involving a leading employee has taken place. No further details about the nature…
    globenewswire health · 19d agoNeutral↗ source
  • Replimune’s Tudriqev immunotherapy receives FDA accelerated approval for advanced melanoma
    Replimune announced that the FDA granted accelerated approval for its immunotherapy, now branded Tudriqev, in combination with Bristol Myers Squibb’s Opdivo. The decision follows two earlier reject…
    BioSpace · 19d agoApprovalPositive↗ source
  • FDA grants accelerated approval to Replimune’s melanoma therapy Tudriqev after two prior rejections
    The Food and Drug Administration has granted accelerated approval to Replimune’s RP1 treatment, which will be marketed under the name Tudriqev, for patients with advanced melanoma. An advisory com…
    STAT · 19d agoApprovalPositive↗ source
  • Takeda receives FDA approval for Orzeyful, first orexin agonist to treat all symptoms of narcolepsy type 1
    Takeda announced that the U.S. Food and Drug Administration has approved its drug oveporexton, which will be marketed under the name Orzeyful, for the treatment of narcolepsy type 1 in adults. The…
    BioSpace · 20d agoApprovalPositive↗ source
  • FDA approves first mRNA seasonal flu vaccine, mFlusiva, a year after funding cuts
    The U.S. Food and Drug Administration granted approval to mFlusiva, the first mRNA‑based seasonal influenza vaccine, after its advisory committee voted unanimously that the benefits outweigh the ri…
    STAT · 20d agoApprovalPositive↗ source
  • Study uncovers tau’s role in reversing mitochondrial electron flow, offering new Alzheimer’s drug target
    A Stanford-led research team has identified a previously unknown way that the protein tau disrupts cellular function, adding to its status as a leading target in Alzheimer’s drug development. The…
    STAT · 20d agoPositive readoutPositive↗ source
  • FDA approves Takeda’s narcolepsy drug and the first mRNA flu vaccine
    The U.S. Food and Drug Administration has granted approval to a new narcolepsy treatment developed by Takeda, marking a significant addition to the therapeutic options for the sleep disorder. In a…
    STAT · 20d agoApprovalPositive↗ source
  • Moderna's mRNA flu vaccine mFLUVISA receives FDA approval after earlier filing refusal
    The U.S. Food and Drug Administration initially issued a refusal-to-file letter to Moderna's flu vaccine in February, but a few days later reversed that decision and accepted a revised submission f…
    BioSpace · 20d agoApprovalPositive↗ source
  • FDA approves Moderna's first mRNA flu vaccine for seniors
    The U.S. Food and Drug Administration has granted approval to Moderna’s influenza vaccine for older adults, marking the first licensed flu shot that uses messenger RNA technology. The product, to…
    STAT · 20d agoApprovalPositive↗ source
  • Medicare delay adds seven years before AbbVie drug price talks, advocacy group says
    A consumer advocacy group says a policy change by the Trump administration delayed Medicare’s selection of an AbbVie drug for price negotiations by seven years. The delay occurred as the Centers f…
    STAT · 19d agoRegulatoryNegative↗ source
  • FDA approves Moderna's mRNA flu vaccine for older adults, first of its kind
    The U.S. Food and Drug Administration has granted approval for Moderna's influenza vaccine designed for older adults. This marks the first licensed flu shot that uses messenger RNA technology. The…
    STAT · 20d agoApprovalPositive↗ source