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959 stories matching this filter · ← front page

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  • Scaling CAR-T: The hidden challenge of thousands of patient-specific manufacturing runs
    Legend Biotech and Johnson & Johnson’s Carvykti therapy illustrates the personal connection patients have with CAR-T, but also its unique operating model where each commercial dose is linked to an…
    BioPharma Dive · 10d agoNeutral↗ 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 · 9d agoApprovalPositive↗ source
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Psychiatry & CNS889
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Infectious Disease457
  • Ultragenyx to consider major cost cuts after Angelman drug fails trial
    Ultragenyx announced that its experimental therapy GTX-102 (apazunersen) for Angelman syndrome failed to meet primary and secondary endpoints in a Phase 3 study. The company said there were no dif…
    BioPharma Dive · 10d agoNegative readoutNegative↗ 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
  • B. Braun recalls three lots of 0.9% Sodium Chloride injection due to zinc oxide particles
    B. Braun Medical Inc announced a voluntary recall of three lots of its 0.9% Sodium Chloride Injection USP, 100 mL, packaged in a 150 mL PAB® container. The recall was triggered after testing ident…
    fda medwatch · 10d agoCRLNegative↗ 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 · 10d agoRegulatoryNegative↗ source
  • Superluminal Medicines raises $60 million to advance AI-designed MC4R drug for rare obesity forms
    Superluminal Medicines, an AI-driven drug discovery startup, announced a $60 million financing round aimed at moving its first candidate toward clinical testing. The candidate targets the MC4R G p…
    BioPharma Dive · 10d agoDealPositive↗ source
  • GSK to spend up to $1.3 billion on Hutchmed's dual-target cancer therapy
    GSK announced a deal to acquire the majority rights to Hutchmed's experimental therapy HMPL-A830. The agreement includes an upfront payment of $110 million and potential milestone and royalty payme…
    BioPharma Dive · 10d agoDealNeutral↗ 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
  • Akeso's ivonescimab shows survival advantage over Keytruda in Chinese lung cancer trial
    A new data cut from a study comparing ivonescimab, a bispecific antibody from China-based Akeso, with Merck's Keytruda in patients with non-small cell lung cancer was released. The interim results…
    BioPharma Dive · 10d agoPositive readoutPositive↗ 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
  • 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 · 10d 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 · 10d 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 · 10d agoNeutral↗ source
  • Boston Scientific recalls Infinion CX spinal cord stimulator leads over risk of mechanical stress and fracture
    Boston Scientific issued a recall of its Infinion CX spinal cord stimulator leads after identifying a risk of mechanical stress at the anchor site that can cause high impedance readings or lead fra…
    fda medwatch · 10d agoCRLNegative↗ source
  • FDA issues early alert on Draeger VentStar Resus Neo hoses due to crack risk and potential ventilation failure
    The FDA’s Center for Devices and Radiological Health has released an early alert about a potential high risk issue with Draeger’s VentStar Resus Neo breathing circuit hoses. The alert follows a let…
    fda medwatch · 10d agoRegulatoryNegative↗ 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 · 10d 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 · 10d agoRegulatoryNegative↗ 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 · 10d 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 · 10d agoNeutral↗ source
  • GE HealthCare updates use instructions for Portrait Mobile monitoring software after FDA safety alert
    GE HealthCare has sent a letter to customers using its Portrait Mobile Monitoring Solution devices, advising updated instructions for certain versions of the Portrait Core Services software. The F…
    fda medwatch · 10d agoCRLNeutral↗ 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 · 11d 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 · 11d 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 · 10d agoRegulatoryNeutral↗ source