FDA approves mixing of newly approved Covid-19 booster shots
The US FDA approved the 'mixing and matching' of Covid-19 vaccine booster shots, which will make vaccination more accessible to US residents.
Approvals
ANVISA approves PTC Translarna indication expansion to ambulatory children
Translarna was earlier approved for use by patients aged five years and above with nonsense...
CHMP recommends Moderna’s Covid-19 vaccine booster shot in the EU
The Phase II data showed that the neutralising antibody titers have declined prior to boosting...
FDA approves Bausch + Lomb and Clearside’s macular oedema treatment
The SCS Microinjector provides exclusive access to the eye’s back portion, which is often the...
Russia approves Sputnik V Covid-19 vaccination with flu shot
Sputnik V has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology.
FDA grants EUA for Johnson & Johnson Covid-19 vaccine booster dose
The Vaccines and Related Biological Products Advisory Committee also recommended the authorisation of J&J’s booster shot.
WHO keeps Sputnik V’s EUL process on hold over missing data
The UN body expects the issues to be resolved for the EUL process soon.
India’s CDSCO recommends emergency use for Covaxin in children
Recommendations based on clinical trial data have been sent to the Drugs Controller General of India (DCGI) for final approval.
Merck seeks EUA for molnupiravir to treat Covid-19 in the US
The EUA application for molnupiravir is based on positive results obtained from the Phase III MOVe-OUT clinical trial.
Brii Biosciences files EUA with US FDA for Covid-19 combination therapy
BRII-196/BRII-198 is intended to treat non-hospitalised Covid-19 patients at high risk of clinical progression to severe disease.
Australia approves BeiGene’s Brukinsa for Waldenström’s macroglobulinemia
BeiGene’s Brukinsa is currently being evaluated across the world as a monotherapy.
