AbbVie seeks EMA marketing authorisation for preventive migraine therapy
The MAA is based on data from two Phase III trials of atogepant in adult patients with episodic and chronic…
Clinical Trials
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EMA CHMP recommends AstraZeneca-Merck’s Lynparza for breast cancer
The latest development is based on findings from the global Phase III OlympiA trial of Lynparza.
GSK to invest $1.2bn in infectious diseases R&D in lower-income countries
The company has established a non-commercial Global Health Unit to meet the goals.
EC approves Novartis’ Tabrecta for non-small cell lung cancer
The EC approval is based on positive findings from the Phase II GEOMETRY mono-1 clinical trial of Tabrecta.
US FDA grants approval for Merck’s pneumococcal vaccine for children
The latest approval is based on findings from seven trials of the vaccine in infants, children and adolescents.
BioMarin’s Voxzogo obtains Japan’s MHLW approval for achondroplasia
In a Phase III trial, treatment with Voxzogo offered transient declines in blood pressure.
Lilly announces results from SURPASS programme for T2D and obesity therapy Mounjaro
Further trials for pediatric and heart failure patients are currently ongoing.
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EMA accepts Sandoz’s application for high concentration of biosimilar
In a Phase I PK bridging study, Hyrimoz 50 mg/mL2 and Hyrimoz HCF had similar safety and immunogenicity.