Tag: regulatory approval
Only 29% of FDA orphan drug approvals receive matching EMA authorisation
A 13-year analysis of 814 FDA orphan drug approvals found that only 29% received matching EMA authorisation with orphan status,…
UK Approves 47 New Pharmaceutical Manufacturing and Wholesale Dealer Licences in Latest MHRA Review
UK's MHRA has granted 47 new pharmaceutical manufacturing and wholesale dealer licences in its latest regulatory review. The licensing expansion…
Regulatory Agencies Split on New Alzheimer’s Drugs as Hope Meets Uncertainty
Regulatory agencies worldwide are delivering conflicting assessments of novel Alzheimer's treatments, creating uncertainty for millions of patients. The Lancet examines…
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