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Analysts at Jefferies called the approval “highly significant,” estimating it could add $2 billion to $3 billion to peak Enhertu sales.
Ambros Therapeutics’ non-opioid bisphosphonate analgesic, already approved in Italy, will soon begin a pivotal test in the U.S.
Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a Phase III study testing Tecvayli plus Darzalex in patients with relapsed or refractory multiple myeloma.
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
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.
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.
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.
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.
The FDA had previously turned back the heart rhythm nasal spray twice, once in late 2023 with a refusal to file letter and again in March this year, when it flagged manufacturing issues.
For $950 million upfront, Sobi will gain ownership to pozdeutinurad, an oral URAT1 inhibitor that performed well in Phase II studies.
The FDA’s Vinay Prasad recently claimed in an internal memo that at least 10 children have died from coronavirus vaccines, but an internal safety review showed that the count was much lower.
As clinical research evolves, disruptive trial designs are reshaping how oncology advances. By integrating novel methodologies, strategic innovation, and patient-centered approaches, MEDSIR is driving a new era in cancer research, one that accelerates development, enhances efficiency, and delivers more meaningful therapeutic progress for patients worldwide.
PRESS RELEASES
Source plant is widely regarded as one of the most valuable fragrance raw materials in the world Stage 2 contract follows successful Stage 1 completion in March 2026
Key Regulatory Benchmark Met, Differentiating DMX-101 from Traditional Opioid Analgesics Late-Breaking Results to be Presented at CPDD 2026 Annual Meeting
Live virtual fireside chat — investors, advisors, and life sciences analysts invited to attend Featuring Dermatologist Mary Spellman, M.D., with Phio CEO Robert Bitterman and Force Family Office CEO Steven Saltzstein
· First-in-class oral mechanism triggers natural satiety hormones, addressing key limitations of GLP-1 therapies · Phase I data demonstrate fat mass reduction, preservation of lean mass, 80% responder rate, and no serious adverse events
