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Manufacturing
Big Pharma Pushes FDA To Decouple Inspections From Drug Approval Applications
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
December 16, 2025
·
4 min read
·
Nick Paul Taylor
Press Releases
OS Therapies Announces Successful Type C Meeting with US FDA Regarding Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
December 15, 2025
·
9 min read
Press Releases
CBIH: Potential Rescheduling to Schedule III Could Reward Decades of Scientific Preparation and Regulatory Discipline
December 15, 2025
·
3 min read
Press Releases
Apyron Pioneering Next Generation Pain Management Solutions
December 15, 2025
·
2 min read
Press Releases
TempraMed Strengthens Global Intellectual Property Position with Grant of South Korean Patent
December 15, 2025
·
6 min read
Cancer
Immunome Heads to the FDA With Desmoid Tumor Drug After Phase III Sweep
Varegacestat, a gamma secretase inhibitor, significantly improved progression-free survival while also meeting all key secondary endpoints in the pivotal RINGSIDE trial. Immunome is planning an FDA application for the second quarter of 2026.
December 15, 2025
·
2 min read
·
Heather McKenzie
Autoimmune disease
Sanofi Taps Dren Again in up to $1.7B Autoimmune Partnership
Sanofi bought Dren’s DR-0201 program earlier this year for $600 million upfront and is running two Phase I trials in undisclosed inflammatory indications.
December 15, 2025
·
1 min read
·
Annalee Armstrong
Autoimmune disease
Argenyx’s Vyvgart Flops Phase III Thyroid Eye Disease Test, Raising Risk for Ongoing Trials
Vyvgart, an FcRn inhibitor already approved for generalized myasthenia gravis, is also being tested in myositis, Sjögren’s disease and the “clinically related” Graves disease.
December 15, 2025
·
1 min read
·
Annalee Armstrong
Multiple sclerosis
Sanofi’s MS Drug Fails Phase III Trial, While FDA Again Delays Approval Application
Sanofi’s multiple sclerosis hopeful tolebrutinib faced dual setbacks on Monday, with a late-stage failure in one form of the disease and yet another regulatory setback in another.
December 15, 2025
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2 min read
·
Annalee Armstrong
Press Releases
Algia Pharma Gains FDA Support to Advance Novel Non-Opioid Pain Treatment Toward a Phase 2 Clinical Trial After IND-Enabling Studies With Indication Expanded to All Mild-to-Moderate Acute Pain
December 15, 2025
·
3 min read
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