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Manufacturing
FDA’s Manufacturing Designation Could Derisk Mid-Development Manufacturing Changes
The status could support staged transitions to new manufacturing processes, potentially mitigating some risks of high-stakes switches.
December 9, 2025
·
4 min read
·
Nick Paul Taylor
China
With Chinese Assets in Hand, Pharma Is Wondering What Else Can Be Learned
What China is accomplishing in R&D “has implications for everyone playing in the R&D or innovation world,” McKinsey’s Fangning Zhang says.
December 9, 2025
·
3 min read
·
Annalee Armstrong
Policy
As FDA Deploys Agentic AI, Pharma Begins Testing the Next Frontier of Intelligent Automation
The agency’s sweeping rollout and staff challenge underscore rising momentum behind agentic AI: advanced, multiagent systems now fueling early pilots in medical writing, patient engagement and regulatory workflows across the industry.
December 8, 2025
·
3 min read
·
Jennifer Smith-Parker
Weight loss
Wave Soars on Early Results for Obesity Treatment That Could ‘Disrupt’ the Landscape
Although still in Phase I, Wave Life Sciences’ injectable RNA weight loss treatment achieved results that impressed analysts, with 4% fat reduction after three months, beating Novo Nordisk’s semaglutide at a similar time point.
December 8, 2025
·
1 min read
·
Dan Samorodnitsky
Press Releases
Coherus Announces Six-Year JUPITER-02 Follow-up Results Showing LOQTORZI® plus Chemotherapy Nearly Doubles Median Overall Survival in Nasopharyngeal Carcinoma
December 8, 2025
·
21 min read
Press Releases
Menarini Group Presents Elacestrant (ORSERDU®) Phase 2 Combination Data in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2025 San Antonio Breast Cancer Symposium
December 8, 2025
·
10 min read
Press Releases
CytoDyn to Showcase PD-L1 Upregulation and Improved Survival in Metastatic Triple Negative Breast Cancer at the San Antonio Breast Cancer Symposium
December 8, 2025
·
5 min read
Press Releases
Ernexa Therapeutics Presents New Preclinical Data at American Society of Hematology (ASH) Annual Meeting on Lead Cell Therapy Candidate for Treatment of Ovarian Cancer
December 8, 2025
·
5 min read
Press Releases
Pierre Fabre Pharmaceuticals Announces Updated Phase 3 Tabelecleucel Data at American Society of Hematology Meeting in Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)
December 8, 2025
·
7 min read
Press Releases
Astrin Biosciences Announces Scientific Advisory Board to Advance Early Cancer Detection Leveraging AI and Proteomics
December 8, 2025
·
3 min read
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