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Priority Review was based on results from the Phase III Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis.

Dan Monahan will serve in the role as the drug goes through Phase III trials.

‘Shape Shifting’ is a creator-led series that focuses on the scientific and cultural impact of GLP-1s.

Abrysvo and Arexvy will now be required to come with labeling that includes a warning about a potential increased risk of Guillain-Barré Syndrome.

The campaign will include patient stories, education resources, and is being held in partnership with the Glaucoma Research Foundation.

Mary Kosinski joined the firm as global managing director for the sector, along with other leadership additions.

This acquisition will help generate data from over four million members of MyHealthTeams’ opted-in patient universe.

Both companies have produced AI-powered technology that improves data collection and analysis.

The future is bright with AI-powered innovations, but migration presents significant risks, including data loss, increased costs, and disruption to business operations.

Fast Track designation was based on results from a Phase II study, which demonstrated that VGT-309 was safe, well-tolerated, and enhanced tumor visualization in lung cancer patients.

Breakthrough Therapy Designation for GSK5764227 was based on data from the ARTEMIS-002 Phase II trial, which demonstrated promising efficacy and safety in 42 osteosarcoma patients.

Guidance marks the regulatory body’s first on artificial intelligence applications in drug and biological product development.

The designation marks VGA039 as the first drug candidate to receive FDA Fast Track designation for von Willebrand disease.

Data from the Phase III trial program found that AXS-05 demonstrated statistically significant efficacy in treating Alzheimer disease agitation.

John Hood, CEO, Endeavor BioMedicines discusses a potential timeline on availability of ENV-101 for patients with IPF and further validation of the treatment's safety profile.

The campaign is focused on the drug’s ability to fight hunger cravings.

The partnership will allow CMI to use Anoki’s AI technology to provide targeted advertising.

Under terms of the deal, Johnson & Johnson will gain an exclusive license to the STAT6 program, with Kaken maintaining commercialization rights in Japan.

PCV21 is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter a Phase III clinical trial in infants and toddlers.

A Q&A with Harvard’s Laura Wegner, serial entrepreneur and Rhodes Scholar-elect.

GlobalData’s new findings show that the Zepbound may become the top WLM in the coming year.

Approval of Tevimbra was supported by the RATIONALE-305 Phase III trial, which demonstrated a significant overall survival benefit in patients with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

Approval was based on results from the Phase III CheckMate-67T trial, which demonstrated non-inferior pharmacokinetics compared to intravenous Opvido.

Check out our top five most engaged social media posts from the year 2024.

John Hood, CEO, Endeavor BioMedicines discusses the key differences between ENV-101 and currently approved IPF treatments.

Approval marks the first generic version of liraglutide injection, referencing Victoza, for improving glycemic control in adults and children aged 10 years and older with type 2 diabetes, alongside diet and exercise.

Approval was based on positive results from the Phase III balance study, where Tryngolza demonstrated a notable placebo-adjusted triglyceride reduction at 12 months.

Accelerated approval was based on promising results from the ongoing Phase III BREAKWATER trial.