A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...
The Brighterside of News on MSN
FDA-approved drug may slow brain cell death in Alzheimer’s patients
Long before memory problems appear, your brain may already be losing neurons. That is the unsettling message from new work by ...
In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...
Milestone Pharmaceuticals, a Canadian company with a U.S. subsidiary in Charlotte, is starting the new year with its first ...
GlobalData on MSN
FDA increases manufacturing flexibility for cell and gene therapies
Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.
AB-1009 is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. For more information, ...
Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...
In this part 3 of our three-part interview, Stenberg explores the evolving manufacturing paradigm in the pharmaceutical ...
The FDA accepted Besremi's application for essential thrombocythemia, supported by SURPASS-ET and EXCEED-ET trial results, with a review target date of August 30, 2026. Essential thrombocythemia is a ...
Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The ...
Last year, the Food and Drug Administration approved the first at-home test that can detect three common infections in women ...
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