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286 stories matching this filter · ← front page

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  • FDA issues complete response letter rejecting ITM Isotope's radiopharma therapy over manufacturing concerns
    FDA sent a complete response letter rejecting the NDA for ITM Isotope's investigational radiopharmaceutical, citing manufacturing and third-party facility issues. The agency said there were no con…
    BioSpace · 9h agoCRLNeutral↗ source
  • Former Legend Biotech chief Ying Huang named CEO of K2, targets $250 million Series A to license Asian assets
    Ying Huang spent the past seven years building one of the leading cancer cell‑therapy companies before stepping down as CEO of Legend Biotech. Weeks after announcing his departure, Huang has taken…
    Endpoints · 11h agoDealPositive↗ source
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Infectious Disease302
  • Swiss startup Vaderis raises $152 million to fund Phase 3 trial of rare bleeding disorder therapy
    Vaderis Therapeutics, a 13‑person Swiss biotech, announced a $152 million Series B financing round aimed at advancing its experimental therapy into a Phase 3 study. The company is testing a treatm…
    Endpoints · 12h agoDealPositive↗ source
  • Silence causes uproar in rare blood cancer space as data sets high bar for competitors
    The mid-stage win of Silence Therapeutics’ siRNA drug in polycythemia vera validates the therapeutic approach of similar assets in development—but also sets a high standard for therapies from Taked…
    BioSpace · 12h agoRegulatoryNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 8h agoLayoffsNegative↗ source
  • Jazz Pharma to acquire Actio Biosciences for up to $1.3 billion, adding experimental KCNT1 epilepsy drug
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, paying $820 million in cash with up to $500 million in milestone payments. The deal is expected to close by the end of the year.…
    BioSpace · 1d agoDealPositive↗ source
  • Silence Therapeutics moves siRNA drug for polycythemia vera to Phase 3 after Phase 2 success
    Silence Therapeutics announced that its siRNA candidate divesiran achieved its primary endpoint in a Phase 2 study in patients with polycythemia vera, a rare blood cancer. The trial results showed…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • AGC Biologics targets in-vivo gene therapies with stable producer lines and next-gen purification
    The industry is moving from ex vivo to in vivo gene delivery, a change that forces viral vector manufacturers to rethink scale, purity, cell lines and analytical methods. In in vivo approaches the…
    BioSpace · 1d agoPositive↗ source
  • Latigo and BlossomHill file Nasdaq IPO plans to fund pain and cancer pipelines
    Latigo Biotherapeutics and BlossomHill Therapeutics, both based in California, have filed applications to list on the Nasdaq Global Select Market. Latigo aims to raise up to $285.2 million to advan…
    BioSpace · 1d agoDealNeutral↗ source
  • BioNTech veteran secures $25M seed round for virtual cancer surveillance startup
    A new virtual cancer surveillance company has closed a $25 million seed round, with the funding led by investors attracted to its novel approach to monitoring tumors. The company is headed by Ryan…
    Endpoints · 1d agoDealPositive↗ source
  • 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 · 4d agoApprovalPositive↗ source
  • FDA schedules September advisory panel to review Grail's cancer test after trial miss
    The FDA announced it will hold an advisory committee meeting in September to examine Grail's multi‑cancer early detection test. The test recently failed to meet its primary endpoint in a large, ra…
    Endpoints · 4d agoRegulatoryNeutral↗ source
  • BlossomHill and Latigo close IPO week with $496 million raised
    BlossomHill Therapeutics, a cancer‑focused biotech, completed its initial public offering this week. Latigo, a company developing non‑opioid pain treatments, also went public at the same time. To…
    Endpoints · 4d agoDealPositive↗ 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 · 5d 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 · 5d 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 · 5d agoDealPositive↗ source
  • FDA approves Moderna flu vaccine
    The U.S. Food and Drug Administration granted approval to Moderna's seasonal flu vaccine, adding another product to the company's portfolio. The approval was announced late Wednesday, after a repo…
    Endpoints · 5d agoApprovalPositive↗ source
  • Revolution Medicines readies launch of experimental pancreatic cancer drug daraxonrasib as approval decision pending
    Revolution Medicines executives say they are preparing to launch daraxonrasib, an experimental therapy for metastatic pancreatic cancer. The drug is currently awaiting regulatory decisions in the…
    Endpoints · 5d agoNeutral↗ 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 · 5d agoNeutral↗ source
  • BioSpace lists top 12 biopharma employers hiring in July 2026
    BioSpace released a list of the twelve biopharma firms with the most job postings in July 2026. The list includes AbbVie, Regeneron, Amgen, Eli Lilly, Sanofi, Novo Nordisk, Moderna, Insmed, Freder…
    BioSpace · 5d agoNeutral↗ source
  • Lilly's Foundayo obesity pill posts $98 million Q2 sales, trails Novo's Wegovy
    Eli Lilly introduced its oral obesity treatment Foundayo after receiving FDA approval in April 2025. The drug entered the market in the second quarter of 2026, marking Lilly's first foray into an o…
    BioSpace · 6d agoNegative readoutNeutral↗ source
  • Analysts spot several biotech firms as likely M&A targets amid rising pharma deal activity
    Pharma companies are actively looking for acquisition opportunities, and analysts have identified a handful of biotech firms that could be next in line for buyouts. Recent transactions have center…
    BioSpace · 6d agoDealNeutral↗ source
  • AstraZeneca and BMS deny merger talks, Reuters says no deal
    Reuters reported that rumors of a merger between AstraZeneca and Bristol Myers Squibb have been dismissed. A senior source close to the matter told Reuters there is no deal and no discussions betw…
    BioSpace · 6d agoDealNeutral↗ source
  • FDA advisory committee meetings sow confusion, threaten trust with rare disease developers
    The Food and Drug Administration has been working to repair its relationship with rare-disease drug makers and patient groups since former commissioner Marty Makary left three months ago. Last wee…
    BioSpace · 6d agoRegulatoryNegative↗ source
  • Gilead pushes into inflammation and oncology as it seeks to diversify beyond HIV franchise
    Gilead reported that HIV remained its strongest franchise in the second quarter, but the company is actively building a pipeline outside virology. CEO Daniel O’Day told investors that diversificat…
    BioSpace · 6d agoNeutral↗ source