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  • Regulators call for unified AI guidelines in drug development at RAPS Convergence 2026
    Regulators and industry experts gathered at RAPS Convergence 2026 in Charlotte, NC to discuss the growing role of artificial intelligence in drug development. The panel highlighted that differing…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA staff flag no major concerns for Grail's multi-cancer test ahead of advisory committee
    FDA staff have completed a review of Grail's multi-cancer early detection test and reported no major concerns. The assessment comes as the test approaches a scheduled advisory committee meeting, w…
    raps · 1mo agoRegulatoryNeutral↗ source
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  • FDA to replace animal testing terms with broader nonclinical language in regulations
    The U.S. Food and Drug Administration announced it will revise its regulations to replace references to animal testing with broader terms such as "nonclinical tests" and "nonclinical studies". The…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Singapore’s Health Sciences Authority expands regulatory partnerships across Africa, Asia and Europe
    Singapore’s Health Sciences Authority (HSA) announced that it is broadening its regulatory reliance and cooperation framework. The agency is establishing new alliances with regulatory bodies in se…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Western licensing deals for Chinese radioligand therapies to jump in 2027, Sleuth forecasts
    Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
    BioSpace · 1mo ago↗ source
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • MHRA AI Commission Issues 44 Recommendations for Future UK Regulatory Framework
    A commission established by the Medicines and Healthcare products Regulatory Agency has released its findings. The group presented 44 recommendations aimed at shaping the United Kingdom’s regulato…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Former FDA chief Califf calls for regulatory overhaul and predicts AI assistants in future oversight
    Robert Califf, who served as FDA commissioner, reflected on his early experience as a medical student in the 1970s working with a pioneering patient database that tracked cardiovascular procedures…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Experts discuss wet AMD treatment limits and need for longer lasting therapies
    In a recent episode of the Denatured podcast, Professor Philip Jacob Rosenfeld of the University of Miami and Wesley Jackson, chief science officer at Valitor, joined host Jennifer C. Smith-Parker…
    BioSpace · 1mo agoNeutral↗ source
  • Over 15,000 Science/R&D jobs and 10,800 Clinical roles posted on BioSpace in first eight months of 2026
    BioSpace data shows seven biopharma disciplines each had at least 5,000 live postings during the first eight months of 2026. Science/R&D leads with 15,361 positions, ranging from manager roles at…
    BioSpace · 1mo agoNeutral↗ source
  • FDA officials stress administration priorities in draft PDUFA VIII commitment letter
    At a public meeting on Wednesday, FDA officials presented the proposed commitment letter for the upcoming PDUFA VIII program. The letter reiterates the administration's priorities, reflecting the…
    raps · 1mo agoRegulatoryNeutral↗ source