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pharmadog newsMonday, November 9, 2026

News

5,715 stories on the wire

Top Story

FDA opens investigation into Novartis' Zolgensma after cancer cases reported

The U.S. Food and Drug Administration announced on Friday that it is opening a formal investigation into the gene-therapy product Zolgensma, marketed by Novartis for spinal muscular atrophy. The agency said it has identified a serious risk of cancer that appears to be linked to the treatment, prompting the probe. Novartis disclosed the occurrence of cancer cases in patients who received Zolgensma the day before the…

Endpoints·1d ago↗ source
RegulatoryNegative

AbbVie and BMS each secure FDA approval, but impact of their neuro‑drug acquisitions remains uncertain

AbbVie and Bristol Myers Squibb have both received FDA clearance for new Parkinson's treatments, prompting a fresh look at the large neuro‑focused deals they completed last year. AbbVie bought Cere…

BioSpace·3h ago
DealNeutral

FDA launches Rare Disease Framework to embed patient input early in drug development

FDA's Center for Biologics Research and Evaluation (CBER) director Karim Mikhail announced a new Rare Disease Framework Initiative aimed at moving patient perspectives from an optional, late‑stage…

BioSpace·3h ago
RegulatoryPositive

Gene therapy sponsors urged to address six GMP manufacturing considerations early

SK pharmteco’s chief technical officer Tatiana Nanda explained that gene therapy sponsors need to think about manufacturing issues well before reaching GMP production. She told BioSpace that early…

BioSpace·3h ago
Neutral
  • Oncology12165
  • Rare Disease3133
  • Immunology2826
  • Cardiology2584
  • Hematology2115
  • Pulmonology2110
  • Vaccines1771
  • Psychiatry & CNS

Latest

  • 23h agoRecent heart-drug trials miss endpoints, raising doubts about AI-driven drug designSTAT
  • 11h agoVir Biotechnology reports positive results for hepatitis D combo in first pivotal trialEndpoints
  • 10h agoStudy finds training bystanders and responders does not boost survival after sudden cardiac arrestSTAT
  • 1d agoBiotech Trade Group BIO Sues Over Medicare GLOBE Pricing PilotSTAT

Browse & Filter

Search all 5,715 stories. Filter by source, therapy area and date range; save views and export CSV.

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1162
  • Ophthalmology984
  • Endocrinology & Metabolism768
  • Pain766
  • Nephrology735
  • 1d agoNovo and Novartis see heart drug setbacks as trials show minimal efficacyEndpoints
  • 1d agoNovo Nordisk’s anti-inflammatory drug ziltivekimab fails to cut heart events, but cardiologists still eye inflammation pathwaySTAT
  • 1d agoDemocrats Take House, Raising Questions for Biopharma PolicyEndpoints
  • 1d agoNew studies highlight hurdles in lowering blood pressure after stroke or in diabetes patientsSTAT
  • 1d agoSTAT+: Failure of Novartis Lp(a) drug raises questions about cardiovascular strategySTAT
  • 2d agoHarvard scientist George Church quits AI startup Radical, alleging partner stole his creditEndpoints
  • 2d agoFDA grants accelerated approval to J&J's Rybrevant for recurrent head and neck cancerEndpoints
  • 2d agoNovartis reports nine cancer cases in patients treated with Zolgensma gene therapyBioPharma Dive
  • Most Covered

    1. 1
      CLINUVEL to cut up to 20% of staff and move headquarters to New York
      BioSpace · 2d ago
    2. 2
      Novo claims 80% share of oral GLP-1 market as rivalry with Lilly intensifies
      BioSpace · 4d ago
    3. 3
      China targets five $1 billion blockbuster drugs by 2030, two already achieved
      BioSpace · 5d ago
    4. 4
      Novo Nordisk lifts 2026 profit outlook after Wegovy obesity pill beats forecasts
      BioPharma Dive · 4d ago
    5. 5
      Novo Nordisk’s oral Wegovy sales beat forecasts, boosting shares over 5%
      BioPharma Dive · 2d ago
    6. 6
      FDA launches Rare Disease Framework to embed patient input early in drug development
      BioSpace · 3h ago

    ranked by linked company, drug, and topic mentions · past 7 days

    By Source

    • STAT1,748
    • Endpoints1,363
    • BioSpace678
    • Fierce Biotech677
    • BioPharma Dive513
    • raps227
    • onclive165
    • fda recalls110
    • fda medwatch
    103
  • globenewswire health73