The FDA has delayed tolebrutinib’s review date again, as Sanofi also posted a Phase III failure for the MS candidate.
Lilly is investigating the triple G agonist retatrutide in seven other Phase III trials, which are due to read out in 2026.
Speaking at CDMI Europe 2025, GlobalData pharma analyst George El-Helou says the use of AI in R&D could help mitigate patent ...
Annual Meeting, held on 6-9 December, results from the global, multicentre, open-label, randomised, Phase III EPCORE FL-1 ...
Immunome’s acquired gamma secretase inhibitor, varegacestat, has demonstrated its efficacy and tolerability in a Phase III study, meaning the company will now file for the drug’s approval with the FDA ...
The solution leverages AI to match molecular, demographic, and clinical history data against eligibility criteria from active trials. Credit: MUNGKHOOD STUDIO / Shutterstock.com. Anova Enterprises has ...
MajesTEC-3 gives J&J a way to keep Darzalex relevant beyond its 2029 patent cliff. Credit: aipicte via Shutterstock. At the American Society of Hematology (ASH) Annual Meeting 2025, held in Orlando, ...
Dyne Therapeutics reported six-month and 24-month data from the Phase I/II trial. Image credit: Sheldon Cooper / SOPA Images / LightRocket via Getty Images. Dyne Therapeutics is seeking US accelerated ...
The safety profile of atogepant over the 24-week period aligned with earlier studies of its use in migraine prevention, with no new safety signals observed. Credit: Komsan Loonprom / Shutterstock.com.
The new pathway was announced by FDA commissioner Martin Makary and CBER director Vinay Prasad in a New England Journal of Medicine article. Image credit: Net Vector / Shutterstock.com. The US Food ...
MSD’s T-cell engager, MK-1045, has demonstrated its tolerability and efficacy in a Phase Ib/II study in B-cell acute lymphocytic leukaemia (B-ALL). Image credit: HJBC via Shutterstock.com. MSD said ...
Capricor’s stock shot up by 371% after it announced the HOPE-3 data. Image credit: Lightspring / Shutterstock.com. Capricor Therapeutics’ stock has soared by more than 370% after a pivotal trial of ...
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