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July 20, 2023
The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.
The new drug may help vulnerable children resist RSV in the coming fall and winter season.
July 17, 2023
Westlake’s third fund of $450 million will be used to grow early stage biotechnology companies.
July 13, 2023
Laboratoire HRA Pharma norgestrel is the first daily tablet for nonprescription use to prevent pregnancy.
Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.
The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.
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 06, 2023
EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.
Full Marketing Authorization has been granted for Novavax’s COVID-19 vaccine by the European Commission.
July 05, 2023
FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.