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  • ADARx, backed by AbbVie, files for IPO to fund clinical-stage siRNA programs
    ADARx Pharmaceuticals, a San Diego biotech supported by AbbVie, announced plans to pursue an initial public offering. The company says most of the IPO proceeds will be used to advance three clinic…
    Fierce Biotech · 7d agoDealPositive↗ source
  • Roivant’s inhaled pulmonary hypertension drug mosliciguat shows strong Phase 2 results
    Roivant invested $14 million in Bayer's inhaled soluble guanylate cyclase activator mosliciguat after a $294 million biobucks agreement in 2024, and promptly advanced the candidate into a Phase 2 s…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
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  • FDA grants accelerated approval for Etcamah combo therapy for advanced HR-positive, HER2-negative breast cancer
    The U.S. Food and Drug Administration announced accelerated approval of Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone-receptor-positive, HER2-negativ…
    fda press · 9d agoApprovalPositive↗ source
  • AbbVie’s etentamig shows strong survival and response gains in Phase 3 multiple myeloma trial
    AbbVie reported that its investigational bispecific T‑cell engager, etentamig, significantly reduced the risk of disease progression or death in a Phase 3 study of patients with relapsed or refract…
    BioSpace · 10d agoPositive readoutPositive↗ source
  • Ionis secures FDA approval for zilganersen, a first treatment for Alexander disease
    Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its antisense drug zilganersen for the treatment of Alexander disease, an ultra‑rare neurodegenerative disord…
    Fierce Biotech · 10d agoApprovalPositive↗ source
  • Menarini to launch Gan & Lee’s GLP-1 drug bofanglutide across Europe in $771 M partnership
    Italian firm Menarini Group has entered a licensing agreement with Chinese insulin producer Gan & Lee Pharmaceuticals to bring the GLP-1 compound bofanglutide to Europe. The deal includes an upfro…
    Fierce Biotech · 10d agoDealPositive↗ source
  • Novartis' Lp(a) drug pelacarsen fails to cut heart attack or stroke risk in phase 3 trial
    Novartis, in partnership with Ionis, completed the phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide designed to lower lipoprotein(a) levels. The study enrolled more than 8,30…
    Fierce Biotech · 9d agoNegative readoutNegative↗ source
  • FDA issues guidance to prevent newborn nutrition supply gap
    The U.S. Food and Drug Administration announced it is taking action to address a potential supply gap of neonatal starter parenteral nutrition, which provides essential IV nutrients to premature an…
    fda press · 9d agoRegulatoryPositive↗ source
  • Truist sees biotech rebound as M&A hits $136B and XBI climbs 34% in H1
    Truist Securities says the biotech sector is regaining momentum after a prolonged post‑pandemic slowdown, driven by rising merger activity, returning venture capital and easing policy risks. The S…
    BioSpace · 9d agoPositive↗ source
  • Pfizer transfers Seagen ADC PF-08046031 to Medicus, adds $12M upfront payment amid acquisition doubts
    Pfizer has moved primary responsibility for an investigational antibody‑drug conjugate, PF‑08046031, to Medicus Pharma as part of its $43 billion Seagen acquisition. Under the license, Medicus wil…
    BioSpace · 9d agoDealNegative↗ source
  • Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapies
    Industry stakeholders have asked the U.S. Food and Drug Administration to expand the scope of its recent draft guidance on scientifically valid prior knowledge for gene therapies that involve genom…
    raps · 10d agoRegulatoryNeutral↗ source
  • MassBio and SCbio select 10 life science startups for Drive accelerator
    MassBio and SCbio announced that ten early‑stage life‑science companies have been chosen for the fall cohorts of the Drive accelerator program. The selection includes five biotech firms and five te…
    BioSpace · 9d agoPositive↗ source
  • FDA approves Zanvastro, first therapy targeting protein buildup in Alexander disease
    The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in both pediatric and adult patients. Zanvastro is the first FDA-approve…
    fda press · 10d agoApprovalPositive↗ source
  • Ultragenyx’s Angelman therapy fails Phase 3, stock drops over 43% and company announces strategic review
    Ultragenyx reported that its investigational Angelman syndrome drug apazunersen did not meet the primary cognitive endpoints in a Phase 3 trial. The lack of efficacy means the therapy will not prov…
    BioSpace · 11d agoNegative readoutNegative↗ source
  • Summit and Akeso's ivonescimab beats Merck's Keytruda in Chinese NSCLC trial
    Summit Therapeutics and Akeso reported that their bispecific PD-1/VEGF antibody ivonescimab outperformed Merck's Keytruda in a Phase 3 HARMONi-2 trial conducted in China. The study enrolled first‑l…
    BioSpace · 10d agoPositive readoutPositive↗ source
  • 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 · 11d 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 · 10d agoApprovalPositive↗ source
  • 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 · 10d 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 · 11d 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 · 11d agoDealPositive↗ source
  • FDA alerts hospitals to purge cassette fault in Abiomed Impella controllers
    The FDA issued an Early Alert after identifying a problem with the purge cassette recognition in Abiomed’s Automated Impella Controllers, which could cause prolonged delays in mechanical circulator…
    fda medwatch · 11d agoRegulatoryNegative↗ 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 · 11d 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 · 10d 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 · 10d 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 · 10d agoRegulatoryNeutral↗ source