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1,610 stories matching this filter · ← front page

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  • AbbVie’s bispecific T‑cell engager etentamig shows positive phase 3 results in relapsed/refractory multiple myeloma
    AbbVie reported that its bispecific T‑cell engager etentamig met its primary goals in the phase 3 Cervino trial for patients with relapsed or refractory multiple myeloma. The trial demonstrated hi…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • FDA approves Ionis’ Zanvastro as first disease-modifying therapy for Alexander disease
    The U.S. Food and Drug Administration has granted approval to Ionis Pharmaceuticals' antisense oligonucleotide Zanvastro, the first therapy that modifies disease progression for Alexander disease.…
    BioSpace · 2mo agoApprovalPositive
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  • Revolution Medicines' Rasonque shows 42% response and 16-month survival in NSCLC subgroup
    Data from a subgroup of an earlier trial, described by Truist Securities as the most relevant to Revolution Medicines' ongoing Phase 3 study, reported a 42% overall response rate and a median overa…
    BioSpace · 2mo agoPositive readoutPositive↗ source
  • Pfizer sells Seagen-derived ADC to Medicus Pharma for $12 million upfront, potential $1 billion milestones
    Pfizer has transferred rights to an antibody‑drug conjugate it acquired in its Seagen purchase to Medicus Pharma. Medicus will pay $12 million upfront and $15 million a year later, and Pfizer coul…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • GSK agrees $1.3 billion deal with Hutchmed for early-stage KRAS-EGFR cancer candidate
    GSK will pay $110 million upfront to Hutchmed as part of a deal that could reach $1.295 billion, giving GSK worldwide rights to develop and commercialize a preclinical oncology asset. The asset, i…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Ultragenyx's Angelman gene therapy fails Phase 3, company to cut expenses
    Ultragenyx reported that its late‑stage Aspire trial of apazunersen in Angelman syndrome did not meet its primary or secondary endpoints. The primary goal of improving the Bayley‑4 cognitive raw sc…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • TScan Therapeutics slashes 75% of staff as it pivots to solid tumor program
    TScan Therapeutics announced on Sept. 2 that it is cutting roughly 75% of its workforce, about 104 employees, as part of a strategic reorganization. The move follows a November 2025 layoff that el…
    BioSpace · 2mo agoLayoffsNegative↗ source
  • ARPA-H allocates up to $125 million to accelerate personalized RNA therapy manufacturing
    ARPA-H announced a new program, called GIVE, that will provide up to $125 million in research funding to develop faster, decentralized manufacturing methods for individualized RNA‑based genetic med…
    BioSpace · 2mo agoRegulatoryPositive↗ source
  • FDA requests public input to accelerate botanical drug product development
    The U.S. Food and Drug Administration issued a request for information (RFI) to collect public comments on ways to move botanical drug products forward. Botanical drug products are derived from pl…
    fda press · 2mo agoRegulatoryNeutral↗ source
  • GSK pays $110 million upfront for exclusive rights to HUTCHMED’s dual-target cancer therapy HMPL-A830
    GSK announced a partnership with Hong Kong-based HUTCHMED, paying $110 million upfront for exclusive global rights to develop HMPL-A830. HMPL-A830 is an investigational antibody-targeted therapy c…
    BioSpace · 2mo agoDealPositive↗ source
  • Senior FDA official overrides reviewers to grant Replimune accelerated approval for melanoma drug Tudriqev
    FDA's primary review team recommended rejecting Replimune's melanoma therapy Tudriqev, saying the company had not adequately addressed key deficiencies noted in earlier complete response letters.…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • Biopharma seeks data scientists as U.S. job market projected to grow 35%
    Biopharma companies are ramping up hiring for data scientists as the U.S. Bureau of Labor Statistics forecasts a 35% increase in data science jobs over the next decade. The surge reflects the growi…
    BioSpace · 2mo agoNeutral↗ source
  • FDA grants emergency use authorization for Capstar and generic nitenpyram to prevent and treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Capstar (nitenpyram) tablets and updated the EUA for the generic Nitenpyram Tablets. Both products are now authorized…
    fda press · 2mo agoRegulatoryPositive↗ source
  • FDA advisory panels for Capricor and Replimune highlight need for rare-disease specialist input
    Recent FDA advisory committee meetings reviewing therapies from Capricor Therapeutics and Replimune produced markedly different outcomes, underscoring how the agency’s reliance on specialist input…
    BioSpace · 2mo agoRegulatoryNegative↗ source
  • Invivyd appoints chairman Marc Elia as CEO ahead of COVID antibody readout
    Invivyd, an infectious-disease biotech, announced that its chairman Marc Elia will also serve as chief executive officer. Elia, who joined the board in 2022 and helped shape the company's scientif…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Benelux biotech strength hampered by fragmented investment, experts discuss path to unified corridor
    In a recent episode of BioSpace's "Denatured" podcast, host Jennifer C. Smith-Parker talks with Christina Takke of V-Bio Ventures and Mariette van der Velden‑Roesink of Curie Capital about the biot…
    BioSpace · 2mo agoNeutral↗ source
  • Psilocybin prevents chemotherapy-induced neuropathy in mouse study, effects last up to eight months
    Researchers at MD Anderson reported that a single dose of psilocybin given before chemotherapy blocked the development of pain hypersensitivity in mice. The protective effect persisted for up to ei…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • Novartis and BMS pause CAR‑T trials after patient deaths while Revolution Medicines gains early FDA approval for pancreatic cancer drug
    Novartis has placed several trials of its CAR‑T therapy rapcabtagene autoleucel on hold after three patients receiving the treatment died. Bristol Myers Squibb also voluntarily froze its autoimmun…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • BMS faces steep risk if milvexian trial fails, could spark mega-cap merger frenzy
    BMS is heading toward a readout for its oral FXIa inhibitor milvexian, a trial that analysts say could be pivotal for the company's future growth. The recent collapse of merger talks with AstraZen…
    BioSpace · 2mo agoNegative readoutNegative↗ source
  • FDA to tighten oversight of foreign clinical trial sites as China trial volume soars
    FDA officials wrote an editorial stating that inspection access is not an administrative footnote and announced plans to expand oversight of foreign clinical trial sites. The initiative follows th…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • Beyond GLP-1s: Companies eye new obesity drug mechanisms as efficacy plateaus
    The obesity drug market continues to expand, with GLP-1 therapies growing from about $5.5 billion in 2023 to over $55 billion projected for 2033. These agents are used for weight loss, diabetes and…
    BioSpace · 2mo agoNeutral↗ source
  • Novartis signs up to $3.2 billion deal with Korea's Alteogen for subcutaneous drug delivery technology
    Novartis has entered an option and license agreement with Korean biotech Alteogen to use its ALT-B4 subcutaneous delivery platform, a partnership that could be worth up to $3.2 billion if all optio…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • UniQure submits FDA and UK applications for first Huntington’s disease gene therapy
    UniQure has filed a biologics license application (BLA) with the U.S. FDA and a separate submission with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its experimental gene…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • UK regulator suspends new patients from receiving Tavneos (Avacopan Vifor) amid data concerns
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has decided to stop prescribing Tavneos, known locally as Avacopan Vifor, to any new patients. The decision follows the regulator’…
    BioSpace · 2mo agoRegulatoryNegative↗ source
  • H1 partners with Novo Nordisk to build AI-driven data foundation for clinical development
    Clinical trials are becoming more complex and data‑heavy, but decision‑making processes have not kept pace. H1 and Novo Nordisk are collaborating to address this gap. Novo Nordisk’s StudyHub links…
    Fierce Biotech · 2mo agoDealPositive↗ source