Category
Diseases
Disease-area coverage across oncology, infectious disease, rare conditions, metabolic and cardiovascular disease and more — focused on the evidence, the treatments and the access questions in each.
575 articles in this topic.
Articles in this category
11/13/2026
Appropriate Comparator Use for EMA-Approved Drugs Fell From 2011 to 2024
Only 58% of EMA-approved drug indications from 2011 to 2024 had at least one trial population tested against an appropriate comparator. The share fell from 78% of 2011 to 2012 approvals to 39% of 2023 to 2024 approvals. #SyenzaNews #MarketAccess
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11/13/2026
ACS Updates Prostate Cancer Screening Guideline for PSA Testing
"The American Cancer Society has updated its prostate cancer screening guideline, with regular PSA testing for average-risk men aged 50 to 69." #SyenzaNews #ProstateCancer
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11/12/2026
Aspen Gets Approval for Generic Semaglutide in Brazil and South Africa
Aspen Pharmacare has received approval for generic semaglutide in Brazil and South Africa, following Canada in July. Launches in all three markets are expected over the coming months. #SyenzaNews #MarketAccess
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11/10/2026
FDA Adds Warning on NAION Risk with GLP-1 Receptor Agonists
FDA is requiring every GLP-1 receptor agonist label to carry a warning on NAION, a rare eye condition that can cause permanent vision loss. #SyenzaNews #drugsafety #GLP1
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11/10/2026
Factor XIa Inhibitor for Stroke Prevention: FDA Approves Sunharbo
The FDA approved Sunharbo (asundexian), the first factor XIa inhibitor for stroke prevention, for adults after a recent ischemic stroke or high-risk TIA. #SyenzaNews #MarketAccess
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11/10/2026
Enzutrix Patent Dispute Heads to Constitutional Court: Hearing Set for 23 November
The Enzutrix patent dispute goes to South Africa's Constitutional Court on 23 November 2026. UC and Astellas are pursuing damages over the generic prostate cancer drug, while Eurolab argues the patent was never validly obtained. #SyenzaNews #MarketAccess
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11/9/2026
Zepbound and Foundayo telehealth access via Hims & Hers
Eli Lilly and Hims & Hers Health agreed to widen Zepbound and Foundayo telehealth access, with self-pay prices starting at $149 per month. #SyenzaNews #obesity #telehealth
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11/6/2026
M72 tuberculosis vaccine approval in Indonesia: BPOM weighs a fast track
BPOM is drafting a conditional approval route for the M72 TB vaccine and a joint review with the European Medicines Agency, ahead of Phase 3 results.
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11/6/2026
Refixia Nonacog Beta Pegol: INFARMED Recommends Funding for Children Under 12 With Haemophilia B
INFARMED recommends public funding for Refixia nonacog beta pegol in children under 12 with haemophilia B, based on two single-arm trials. #SyenzaNews #MarketAccess
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11/6/2026
Recent Zolgensma safety concerns: what Novartis has reported
SMA Europe has relayed Novartis's figures on tumour reports in patients previously treated with Zolgensma, including two cases of vector DNA integration.
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11/6/2026
Dupilumab Chronic Spontaneous Urticaria: G-BA Finds No Proven Added Benefit
The G-BA has found no proven added benefit for dupilumab in chronic spontaneous urticaria, compared with omalizumab plus second-generation H1 antihistamines.
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11/4/2026
Truqap prostate cancer withdrawal: AstraZeneca pulls EU bid
"Truqap prostate cancer withdrawal: AstraZeneca pulled its EU bid for newly diagnosed use after EMA raised benefit-risk concerns." #SyenzaNews #MarketAccess
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