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Gene therapy gives
hope to patients
with ‘butterfly skin’
FDA approves first gene therapy to treat dystrophic epidermolysis bullosa patients – a condition sometimes called ‘butterfly skin’.
HIV-prevention drug is first to be made in South Africa
Indian firm Cipla is first manufacturer approved to produce generic of the
HIV-preventer cabotegravir, in South Africa.
Novel gene editing method “roughly threefold” better
Researchers from the University of California Santa Barbara (UCSB) have found two ways to boost the capabilities of CRISPR/Cas9.
Changing of the guard at Regulatory Rapporteur
Leslie Dowling, Editor-in-Chief of the Regulatory Rapporteur, for 12 years steps down:
Davina Stevenson set to take on lead of respected journal.
FDA licence for first drug to treat agitation in Alzheimer’s
Rexulti has become the first FDA-approved treatment for agitation associated with dementia due to Alzheimer’s disease.
First anaemia drug for cats given
‘expanded conditional approval’
Varenzin-CA1 is the first drug approved for cats with nonregenerative
anaemia, under the FDA’s expanded conditional approval pathway.
FDA approves world’s first RSV vaccine for use in over 60s
WHO says COVID-19 ‘no longer a global health emergency’
MHRA reappoints two non-exec directors
India backs ambitious expansion in spending to support medical devices
Moderna secures agreement for mRNA facility in Kenya
Ghana approves R21 malaria vaccine; first to exceed WHO’s efficacy target
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UK set to accept CE mark for medical devices until 2028
The MHRA has confirmed an extension to certain CE-marked medical devices being placed on the GB market until June 2028
Northern Ireland deal permits GB medicines but not medical devices
On 27 February 2023, the Government of the United Kingdom (UK) and the EU Commission announced a political agreement in principle on the Windsor Framework.