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  • Ultragenyx receives FDA approval for Fayuvi, first therapy for Sanfilippo syndrome type A, priced at $3.95 M
    The FDA has approved Ultragenyx's gene therapy rebisufligene etisparvovec, to be sold under the brand name Fayuvi, for the treatment of Sanfilippo syndrome type A, an ultra-rare progressive neurolo…
    BioSpace · 1mo agoApprovalPositive↗ source
  • China unveils five-year plan to grow biotech sector from $3M to $522B by 2030
    China's Ministry of Industry and Information Technology released a new five-year biotech plan that sets out ambitious growth targets for the sector. The plan aims to expand the industry from rough…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
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  • Xenon shares tumble up to 30% after pausing depression trial over neuropsychiatric events
    Xenon Pharmaceuticals announced it is pausing enrollment in its depression trial for the drug azetukalner after neuropsychiatric adverse events emerged that were not observed in earlier testing. A…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Electra Therapeutics raises $350M in IPO to fund pivotal immune-disease antibody development
    Electra Therapeutics announced an initial public offering that raised $350 million, exceeding its earlier target. The IPO consisted of 23.3 million shares sold at $15 per share, and underwriters w…
    BioSpace · 1mo agoDealPositive↗ source
  • Xenon shares plunge 23% after voluntary hold on psychiatry trials, despite filing NDA for epilepsy drug
    Xenon Pharmaceuticals announced that its lead asset azetukalner (AZK) has been submitted to the FDA as a new drug application for focal onset seizures. At the same time, the company disclosed a vo…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Electra Therapeutics raises $350M in biotech IPO, fueling rare disease drug development
    Electra Therapeutics completed a $350 million initial public offering, becoming the 21st biotechnology company to go public in 2026. The strong demand for its shares highlights continued investor a…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • GSK adds two China cancer-therapy licensing deals, keeping pace with industry partnership surge
    BioPharma Dive's new visualization series recapped recent activity, spotlighting GSK's licensing agreements in China and the market response. Since the start of 2025, GSK has signed five deals wit…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Ultragenyx prices Sanfilippo gene therapy at $4 million as it gains a second FDA approval; Bristol Myers halts Orum cancer drug
    The FDA approved Fayuvi, the first gene therapy for Sanfilippo syndrome Type A, with a list price of $3.95 million. This marks Ultragenyx's second gene‑therapy approval since August, earning sella…
    BioPharma Dive · 1mo agoApprovalNeutral↗ source
  • BMS drops Orum’s targeted degrader after Phase 1 results
    BMS announced it is ending development of ORM-6151, a degrader‑antibody conjugate acquired from Orum Therapeutics. The decision follows a Phase 1 trial in acute myeloid leukemia and myelodysplasti…
    BioSpace · 1mo agoNegative↗ source
  • FDA faces nominee hearing, hiring woes and reviews of psychedelics and testosterone therapies
    A Senate committee set a hearing for President Trump's pick to lead the FDA, highlighting the political scrutiny of the agency's top leadership. New reporting reveals ongoing hiring challenges at…
    raps · 1mo agoRegulatoryNeutral↗ source
  • GF Blends recalls AIP flour and flatbread mixes over undeclared wheat gluten
    GF Blends announced a recall of its Truly AIP All Purpose Flour and Bread Mix and the EAT G.A.N.G.S.T.E.R. Flat Bread Pizza Mix because testing found undeclared wheat gluten. The products were mad…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
    The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known…
    fda press · 1mo agoApprovalPositive↗ source
  • Novo Nordisk signs up to $1.4 billion deal with Orbis Medicines to develop oral macrocycle cardiometabolic drugs
    Novo Nordisk announced a partnership with Danish biotech Orbis Medicines, valued at up to $1.4 billion, to co-develop oral macrocycle drugs aimed at cardiometabolic diseases. The collaboration wil…
    BioSpace · 1mo agoDealPositive↗ source
  • North Immunology to go public via reverse merger with Aethlon, targeting eczema market
    North Immunology, an early-stage biotech developing a dual-acting antibody for eczema, announced plans to become a public company through a reverse merger with Aethlon Medical. The transaction wil…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Novartis' $12B Avidity deal falters as DM1 therapy misses Phase 3 endpoint
    Novartis' recent acquisition of Avidity Biosciences was intended to bring a novel therapy for Myotonic dystrophy type 1 (DM1) into its portfolio. The drug, del-desiran, an antibody-oligonucleotide…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Novo and Orbis strike up to $1.4 billion partnership to develop oral peptide macrocycles for cardiometabolic disease
    Novo Pharmaceuticals has entered a partnership with fellow Danish firm Orbis Medicines that could be worth as much as $1.4 billion. The agreement includes upfront payments, downstream payouts and r…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Lisata acquires Marea Therapeutics, securing $225M financing to advance two mid-stage drugs
    Lisata Therapeutics completed a stock-for-stock acquisition of biotech startup Marea Therapeutics. The transaction includes a $225 million financing round led by existing backers such as Forbion,…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Biotech sector expected to weather Fed rate hike despite higher capital costs
    The Federal Reserve raised the federal funds rate by a quarter of a percentage point, a move that traditionally weighs on capital‑intensive industries like biotech. Analysts at BMO Capital Markets…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Longeveron shares plunge 57% after stem-cell therapy fails in mid-stage heart trial
    Longeveron announced that its investigational stem cell product, laromestrocel, did not meet its primary endpoint in a Phase 2b study of infants with hypoplastic left heart syndrome (HLHS). The tri…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Roche commits up to $1 billion to develop bispecific antibodies with Dualitas
    Roche announced a partnership with Dualitas Therapeutics, a California biotech, to advance bispecific antibody programs aimed at immunological and inflammatory diseases. The agreement includes an…
    BioSpace · 1mo agoDealPositive↗ source
  • Roche partners with Dualitas Therapeutics in up to $1 billion deal to screen bispecific antibodies for immune diseases
    Roche has committed $36.5 million up front to biotechnology startup Dualitas Therapeutics under a research partnership that could total up to $1 billion in milestone payments and royalties. The agr…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Biopharma hiring surges in Massachusetts and California, with science/R&D and clinical roles leading demand
    BioSpace data shows that biopharma job postings on its site rose 17% between January and August 2026, signaling a broad increase in employment opportunities. Massachusetts and California dominate…
    BioSpace · 1mo agoNeutral↗ source
  • EU officials outline major pharmaceutical legislative reforms at RAPS Convergence 2026
    At RAPS Convergence 2026 in Charlotte, North Carolina, officials from the European Commission and the European Medicines Agency presented a set of reforms aimed at overhauling the European Union’s…
    raps · 1mo agoRegulatoryPositive↗ source
  • Webinar Explores Manufacturing Risks and Partner Strategies for the Next Five Years
    The webinar titled "Manufacturing in Turbulent Times" is scheduled for September 17, 2026 and is designed to help biopharma sponsors understand the manufacturing challenges that lie ahead. It note…
    BioSpace · 1mo agoNeutral↗ source
  • Senate schedules hearing for FDA nominee as Novo teams with Anthropic on AI drug development
    The Senate has announced a hearing to consider the nominee for the next FDA commissioner, signaling a forthcoming review of the agency's leadership. In parallel, biotech firm Novo has entered a pa…
    raps · 1mo agoRegulatoryNeutral↗ source