EMA validates Gilead’s Marketing Authorisation Application for Lenacapavir
Lenacapavir is an investigational, long-acting capsid inhibitor for the treatment of HIV-1 in people with limited therapy options
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Browsing Tag
EMA
EMA recommends marketing authorisation for Scemblix by Novartis
While many patients will benefit from available TKI therapies, a significant proportion may experience intolerance or resistance…
EU drugs watchdog begins review of Moderna’s variant COVID vaccine
The US-based Moderna's so-called bivalent vaccine targets two strains of the SARS-CoV-2 virus behind COVID, the original strain…
Pfizer and BioNTech submit application for US EUA for COVID vaccine booster dose in kids aged five…
The companies also plan to submit these data to the European Medicines Agency (EMA) and other regulatory agencies around the world…
EU regulator asks for more COVID vaccine data from Valneva
Valneva said the EMA Committee for Medicinal Products for Human Use (CHMP) had a fresh list of questions, including requests for…
Britain approves Valneva’s easy-to-store COVID shot
The shot is also the sixth COVID-19 vaccine to be approved in the UK
Drugmakers pledge speedier European market launches to avert stricter regulation
The pledge would reduce the time patients wait for new medicines by four-to-five months in several countries such as Bulgaria,…
Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV…
Celerity Pharma uses Biocon Biologics’ insulin drug substance to develop the product
WuXi STA passes first EMA drug product pre-approval inspection for Wuxi city site
The PAI focussed on the drug product manufacturing of an innovative drug for one of WuXi STA’s partners
US FDA declines to approve Amryt’s topical gel for rare skin diseases
The agency has asked Amryt to submit additional data confirming the effectiveness of the drug