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1,393 stories matching this filter · ← front page

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  • 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 · 4d 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 · 4d agoApprovalPositive↗ source
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  • 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 · 4d 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 · 4d 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 · 4d 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 · 4d 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 · 4d 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 · 5d 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 · 4d 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 · 4d agoApprovalPositive↗ source
  • LifeMine Therapeutics secures $263 million in dual venture rounds to advance organ transplant aftercare drug
    LifeMine Therapeutics announced it has raised a total of $263 million through a $75 million Series D and an $188 million Series F round, opting for private financing rather than an IPO. The capita…
    BioSpace · 4d agoDealPositive↗ source
  • FDA approves first drug for type 1 narcolepsy and greenlights mRNA flu vaccine; AstraZeneca and BMS deny merger talks
    The U.S. Food and Drug Administration has granted approval for the first therapy specifically targeting type 1 narcolepsy, marking a milestone for patients with this rare sleep disorder. In a sepa…
    raps · 5d agoApprovalPositive↗ source
  • Braveheart Bio targets $382 million IPO to fund cardiac drug development
    Braveheart Bio announced an upsized initial public offering on the Nasdaq, aiming to raise about $382.5 million. The company will sell 21.2 million shares at $18 each under the ticker BRVE. The pr…
    BioSpace · 4d agoDealPositive↗ source
  • Sanofi pauses Phase 2 bronchiectasis study of SAR445399 amid new CEO’s portfolio review
    Sanofi has halted a Phase 2 trial of its investigational antibody SAR445399 in non‑cystic fibrosis bronchiectasis. The pause was attributed to strategic business reasons linked to an internal portf…
    BioSpace · 4d agoRegulatoryNeutral↗ source
  • CDC appoints Erica Schwartz as director and Moderna secures approval for mRNA flu vaccine
    The U.S. Centers for Disease Control and Prevention announced that Erica Schwartz has been confirmed as its director, filling a vacancy that has lasted nearly a year. In a separate regulatory upda…
    STAT · 4d agoRegulatoryNeutral↗ source
  • Tenax Therapeutics to Release Phase 3 Heart Failure Trial Results Soon
    Tenax Therapeutics announced that it will soon disclose data from its Phase 3 trial of a heart-failure treatment. The study is being watched as one of the largest binary events left for biotech st…
    STAT · 4d agoNeutral↗ source
  • AI’s role in medicine isn’t monolithic, says industry leader, urging nuanced adoption
    Priya Abani, CEO of health‑tech firm AliveCor, argues that asking whether AI is good for medicine is a question with an obvious answer: it is. She says the debate has become redundant and that the…
    STAT · 4d agoPositive↗ source
  • FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelines
    FDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…
    raps · 5d agoRegulatoryNeutral↗ source
  • BioVie shares plunge as Parkinson’s trial results lack primary motor data
    BioVie reported results of its Phase 2 SUNRISE-PD study in early‑stage Parkinson’s disease. The double‑blind, placebo‑controlled trial enrolled 57 patients who had not yet received carbidopa/levodo…
    BioSpace · 4d agoNegative readoutNegative↗ source
  • Podcast explores emerging rapid‑acting and psychedelic therapies for treatment‑resistant depression
    In a recent episode of BioSpace’s Denatured podcast, host Jennifer C. Smith‑Parker talks with Hans Eriksson, chief medical officer of FundaMental Pharma, and Steve Levine, chief patient officer at…
    BioSpace · 4d agoPositive↗ source
  • Experts call for independent 9/11‑style commission to review U.S. Covid response
    In an opinion piece, IDSA President Ronald Nahass argues that the United States should create a nonpartisan, 9/11 Commission‑style body to examine the Covid‑19 response. He says such an inquiry wou…
    STAT · 4d agoNeutral↗ source
  • Tiziana Life Sciences CEO Ivor Elrifi buys 321,423 shares, raising his stake to 4.79 million
    Tiziana Life Sciences announced that its chief executive, Ivor Elrifi, purchased 321,423 common shares of the company on NASDAQ at $1.00 per share. The transaction brings Elrifi’s total ownership…
    globenewswire health · 4d agoDealPositive↗ source
  • Novo Nordisk reports board and executive share transactions under EU market abuse rules
    On August 6, 2026 Novo Nordisk issued a company announcement detailing share transactions made by members of its board, senior executives and their close associates in line with Article 19 of EU Re…
    globenewswire health · 4d agoRegulatoryNeutral↗ source
  • Tiziana Life Sciences CEO Ivor Elrifi boosts stake, buying 321,423 shares at $1 each
    Tiziana Life Sciences announced that its chief executive officer, Ivor Elrifi, purchased 321,423 common shares of the company on NASDAQ at $1.00 per share. The purchase raises his total holding to…
    globenewswire health · 4d agoDealPositive↗ source
  • Choosing Between CROs and Biotechs: How Company Size Shapes the Fit
    While biotechs and contract research organizations each have strengths, the article notes that the right choice depends on a company’s specific situation. Ali Pashazadeh, founder and CEO of Treehi…
    BioSpace · 4d agoNeutral↗ source