On June 22, 2026, the U.S. Department of Health and Human Services (HHS) announced the launch of Operation TrialBlazer, a coordinated effort ...
Biopharmaceutical developers should introduce risk-based, phase-appropriate characterization strategies for quality control ...
The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical ...
Medical innovation is exciting. It’s thrilling to think a new therapy, device or product can improve the quality of or save lives. Who can’t get behind that? As a result, […] ...
On May 29, 2026, FDA released updated guidance on the content of human factors information required in medical device marketing submissions. This is just the latest signal that usability engineering ...
The tailor-made comprehensive offering spans a diversified clinical and commercial portfolio of innovative modalities, ...
Henny Zijlstra, Chief Commercial Officer of Ardena, discusses the integrated CDMO model, Ardena’s new laboratory in New ...
Drug developers have a new, optimized option for U.S.-based manufacturing, as AGC Biologics enters a strategic partnership ...
The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions ...
The FDA Manufacturing PreCheck Program is a voluntary pilot initiative authorized under Executive Order 14293, designed to ...
Proven bacterial, viral, conjugate, and E.coli expression platforms support partners from discovery and process development to GMP readiness and clinical manufacturing ...
Discusses Accelerated FDA Approval of TRUTAKNA for IgA Nephropathy July 7, 2026 4:30 PM EDTCompany ParticipantsSean Grant ...
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