On 22 November 2019, the European Medicines Agency (“EMA”) published an updated Annex to the European Commission’s Guidelines concerning excipients in the labelling and package leaflet of ...

The first CRISPR–Cas9-based medicinal product, Casgevy (exagamglogene ... Although specific characteristics of GEMPs were taken into account, the advice provided on most clinical aspects was ...

The two active substances are antivirals that inhibit HIV reverse transcriptase through incorporation into the viral DNA, ...

To obtain a marketing authorisation it is necessary to establish therapeutic efficacy and a positive benefit-risk profile for a medicinal product. The sponsor of a clinical trial wishing to obtain ...

In a new study titled, "The Association between Cannabis Product Characteristics and Symptom Relief," published in the journal Scientific Reports, UNM researchers Sarah See Stith, assistant ...

today announced that Advanced Therapy Medicinal Product (ATMP) classification has been granted for SB623 for the treatment of patients with motor deficits arising from Acquired Brain Injury ...