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August 02, 2023
What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?
July 20, 2023
The new drug may help vulnerable children resist RSV in the coming fall and winter season.
July 12, 2023
EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically.
July 11, 2023
FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition
July 05, 2023
FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.
July 02, 2023
Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.
Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.
June 27, 2023
The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.
June 02, 2023
An increase in applications for gene therapies is putting stress on FDA’s resources.
May 31, 2023
Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.