BioSpace News Archive

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  Regulatory

  FDA Pushes Back PDUFA Dates for Amgen and Intercept

  The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic colorectal cancer and Intercept Pharmaceuticals’ Ocaliva for primary biliary cholangitis.

  October 18, 2024

   · 

  2 min read

   · 

  Tristan Manalac
• 

  Editorial

  It’s Earnings Season. Here’s What to Watch for Following J&J Beat

  This week marked the start of the third-quarter earnings season, with Johnson & Johnson exceeding Wall Street’s expectations. Pfizer is projected to have a strong quarter, while Eli Lilly could pull ahead of Novo Nordisk in the obesity space. Moderna, by contrast, has a decidedly negative outlook.

  October 18, 2024

   · 

  4 min read

   · 

  Greg Slabodkin
• Press Releases

  Sage Therapeutics Announces Strategic Reorganization to Prioritize ZURZUVAE® Commercialization and Focus its Development Portfolio

  October 18, 2024

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  9 min read
• Press Releases

  AN2 Therapeutics Receives Continuation Grant to Discover Novel Boron Based Therapies for Tuberculosis (caused by Mycobacterium tuberculosis) and Malaria

  October 18, 2024

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  4 min read
• Press Releases

  Intercept Provides Regulatory Update Regarding sNDA for OCALIVA

  October 18, 2024

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  8 min read
• Press Releases

  Mitsubishi Tanabe Pharma America Unveils New ALS Research Findings at NEALS 2024 Annual Meeting

  October 18, 2024

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  10 min read
• Press Releases

  Tevogen Bio Oncology Reports Top-Line Revenue Forecast of $1 Billion in Launch Year and Cumulative 5-Year Estimate Between $10 Billion and $14 Billion; Forecasts for Non-Oncology Therapeutic Areas to Follow

  October 18, 2024

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  5 min read
• Press Releases

  Nikon Small World Competition Celebrates 50 Years with Groundbreaking Image of Brain Tumor Cells

  October 18, 2024

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  19 min read
• Press Releases

  Multiple Clinical Complete Responses Demonstrated Following Single Low Dose Administration of Bel-sar in Patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) in Ongoing Phase 1 Trial

  October 18, 2024

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  9 min read
• News

  Tenon Medical(R) Announces Issuance of Three U.S. Patents

  October 18, 2024

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  4 min read