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467 stories matching this filter · ← front page

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  • Aspo Oyj announces upcoming leadership changes scheduled for August 10, 2026
    Aspo Oyj, a Finnish specialty chemicals company, issued a brief notice indicating that it will implement leadership transactions. The announcement specifies that the changes will take effect on Au…
    globenewswire health · 15d agoNeutral↗ source
  • Aspo Plc reports managers' transactions on August 10, 2026
    Aspo Plc disclosed that its managers executed transactions on August 10, 2026, as recorded in a filing. The filing does not provide details about the nature, size, or parties involved in the trans…
    globenewswire health · 15d agoNeutral↗ source
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Replimune secures FDA approval for Tudriqev, eyes $1.3 bn peak sales in advanced melanoma
Replimune announced FDA approval of its therapy Tudriqev for patients with advanced melanoma who have progressed after PD-1 treatment. Analysts at BMO Capital Markets project the drug could genera…
BioSpace · 18d agoApprovalPositive↗ source
  • 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 · 18d 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 · 18d agoRegulatoryNeutral↗ 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
  • 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
  • FDA grants emergency use authorization for CLiK Extra wound spray to prevent New World screwworm in livestock and wildlife
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for CLiK Extra, a dicyclanil topical suspension designed to be applied around wounds. The authorization allows the pr…
    fda press · 18d agoRegulatoryPositive↗ 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 · 18d agoNegative readoutNegative↗ 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 · 18d agoNeutral↗ 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 · 18d 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 Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 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 · 19d 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 · 19d 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 · 19d 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 · 20d 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 · 19d 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 · 19d agoRegulatoryNeutral↗ 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 · 20d 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 · 19d 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 · 19d agoPositive↗ source
  • Medline recalls Hudson RCI neonatal heated wire breathing circuits over connector overheating risk
    Medline Industries announced a nationwide recall of its Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. The recall was triggered after the company received reports of sporadic failures i…
    fda medwatch · 20d agoRegulatoryNegative↗ 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 · 19d 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 · 20d agoRegulatoryNeutral↗ source