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News about "Marty Makary"
US FDA Proposes Excluding Semaglutide, Tirzepatide and Liraglutide from 503B Bulks List
The US Food and Drug Administration (FDA) proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, citing no clinical need for compounding these GLP-1 drugs by outsourcing facilities.
Marty Makary | 04/05/2026 | By News Bureau
U.S. Food and Drug Administration grants rapid approval to Tec-Dara, a combination of teclistamab and daratumumab hyaluronidase-fihj, for adults with relapsed or refractory multiple myeloma after at least one prior therapy.
Marty Makary | 07/03/2026 | By News Bureau | 108
FDA Publishes Guidance on Modern Statistical Methods for Clinical Research
The FDA guidance provides a framework for applying Bayesian analyses in clinical research, enabling data-driven assessments of safety and efficacy using both current and prior evidence.
Marty Makary | 14/01/2026 | By News Bureau | 106
Novartis Breaks Ground on Flagship Manufacturing Hub in North Carolina
Novartis has officially begun construction of its flagship manufacturing hub in North Carolina, reinforcing its commitment to end-to-end production of key medicines for US patients. The project, highlighted by FDA Commissioner Marty Makary and Governor Josh Stein, underscores Novartis’ ongoing investment and growth in the US pharmaceutical sector.
Marty Makary | 15/12/2025 | By News Bureau | 389
US FDA Appoints Richard Pazdur as Director of CDER
Pazdur is a 26-year veteran of the FDA and the Founding Director of its Oncology Center of Excellence (CoE). A regulatory innovator, he developed an integrated approach for cross-centre coordination of oncology product review to expedite the development of novel cancer therapies.
Marty Makary | 13/11/2025 | By Dineshwori | 283
Novartis Opens New Radioligand Therapy Plant in California under USD 23 Billion US Expansion Plan
Novartis has inaugurated its third US-based radioligand therapy (RLT) manufacturing facility in Carlsbad, California, expanding its production network to meet growing demand and maintain a 99.9 percent on-time delivery rate for patients across the western United States, Alaska, and Hawaii.
Marty Makary | 12/11/2025 | By Dineshwori | 271
FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs
In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing. The agency, through a separate initiative, also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily.
Marty Makary | 01/11/2025 | By Dineshwori | 229
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