Teva wins US obesity approval for its GLP-1 generic liraglutide
And Eli Lilly and Company’s new oral GLP-1 obesity therapy orforglipron shines in late-phase clinical trials.
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And Eli Lilly and Company’s new oral GLP-1 obesity therapy orforglipron shines in late-phase clinical trials.
The Route B notification pilot will expand the MHRA’s risk-proportionate approach and help prepare for a new modifications process under upcoming regulations.
The Phase III findings could represent a critical advancement in managing the rare autoimmune disease in those with limited treatment options.
While no other country has an identical scheme, analysis of the 2025 payment rate shows the UK is significantly behind comparable countries.
22 August 2025 | By US Pharmacopeia
Watch our webinar with USP as they explored new approaches for impurity profiling - unveiling new frameworks, analytical tools, and regulatory insights that are reshaping pharmaceutical quality standards.
Her leadership experience spans three decades with Lilly, across multiple therapeutic areas including oncology, neuroscience and infectious disease.
The paper explores recent guidance by the EMA and aims to help companies ensure their developments are efficient and effective for the forthcoming transition.
Further to its potential in Stargardt disease, if approved, the one-time gene therapy could become standard of care for retinitis pigmentosa, alongside other retinal degenerative diseases.
In this article, Miguel Angel Ortega Sánchez of ROIS explores how the industry is adapting to new delivery formats, device bottlenecks, and strategic partnership models — and why flexibility, compliance, and tech transfer agility are now critical to success.
Becomes the first monoclonal antibody for the condition to be approved by the MHRA and advances the pharma company’s ambitions in diabetes.
Pharmacokinetic study of the novel drug delivery method shows high relative bioavailability in a once-weekly regimen.
Sven Dethlefs will be tasked with driving its deupirfenidone programme in idiopathic pulmonary fibrosis.
Late-stage trials in Sjögren’s disease and primary immune thrombocytopenia met primary endpoints.
Amid intensifying market competition, the next-generation therapies could shape the future of oncology.
CBER head makes surprise comeback just weeks after his abrupt resignation.