European medicines regulatory network adopts EU common standard for electronic product information
The Product Information (PI) of a medicine includes the package leaflet for patients and the summary of product characteristics…
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European Medicines Agency
Sputnik V due to submit vaccine data to WHO this month
Moscow rushed to approve the shot for domestic use last year and it has been exported to countries around the world, but it has…
EU regulator starts real-time review of Merck’s COVID-19 pill
Under the procedure, also known as a rolling review, the European Medicines Agency (EMA) would assess data as soon as it becomes…
Sacituzumab Govitecan receives positive CHMP opinion as 2L treatment for adult patients with…
Recommendation is based on the phase-III Ascent study showing that Sacituzumab Govitecan significantly improved the overall…
EMA studying data on Pfizer’s COVID-19 vaccine booster dose
The drugmakers filed an application with the European Medicines Agency (EMA) which said it would carry out a speedy evaluation of…
European Medicines Agency (EMA) grants Orphan Designation for AOC 1001
The FDA cleared Avidity to proceed with the phase-I/II Marinatm trial of AOC 1001 in adults with myotonic dystrophy type 1 (DM1)…
EMA validates Bristol Myers Squibb’s two Opdivo-based applications to treat cell carcinoma
The applications are based on positive results from the phase-III CheckMate-648 trial, in which both Opdivo-based combinations…
FDA accepts application for Roche’s Faricimab
If approved, Faricimab would be the first and only medicine designed to target two distinct pathways that drive retinal diseases…
EMA grants Orphan Drug Designation to Saroglitazar Mg for treating patients with PBC
The Orphan drug status in Europe is given to medicines with the potential to be safe and effective treatments for rare,…
EU begins real-time review of Sanofi-GSK COVID-19 vaccine
The decision to start the "rolling review" of the vaccine, Vidprevtyn, was based on preliminary results from lab studies and…