Europe – Global regulators agree on way forward to adapt COVID-19 vaccines to emerging...
International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and the need for and strategy to update their composition...
Europe – EU regulator recommends revoking approval for Novartis’ sickle cell disease drug
The European Medicines Agency’s (EMA) human medicines committee has recommended revoking the conditional marketing authorisation for Novartis’ sickle cell disease (SCD) drug Adakveo (crizanlizumab).
The...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Two new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended two medicines for approval at its May 2023 meeting.
The committee recommended granting a marketing...
Europe – EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo
EMA’s human medicines committee (CHMP) has recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises) in patients aged...
UK – SKYCovion COVID-19 vaccine authorised by MHRA
SKYCovion, the COVID-19 vaccine developed by SK Chemicals, has today been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
It becomes the 8th...
UK – MHRA announces new recognition routes to facilitate safe access to new medicines...
New regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States,...
UK – Regulatory approval of Pfizer/BioNTech vaccine for COVID-19
There are four presentations of the original COVID-19 Vaccine Pfizer/BioNTech authorised for use in Great Britain, three of which are currently available and all...
UK – Bayer’s Nubeqa combination recommended by NICE to treat metastatic prostate cance
The final draft guidance from NICE specifically recommends Nubeqa tablets in combination with androgen deprivation therapy (ADT) and docetaxel.
The decision follows the Medicines and...
UK – AstraZeneca’s heart failure treatment recommended by NICE for expanded use
Forxiga, sold as Farxiga in certain markets, has previously been recommended by NICE as a treatment option for HF patients with reduced ejection fraction...
UK – MSD and Eisai’s combination therapy recommended by NICE for advanced endometrial cancer
The combination therapy is specifically indicated for adults with advanced or recurrent endometrial cancer whose disease has progressed on or after platinum-based chemotherapy and...
