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July 24, 2023
The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.
July 20, 2023
These recommendations will keep key antibiotics for respiratory infections available when they are needed most.
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 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 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 06, 2023
EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.