US orders additional 100 mn doses of Moderna’s COVID-19 vaccine
Total of 200 million doses ordered by the US government to date, it retains option to purchase up to an additional 300 million…
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Browsing Tag
EMA
Gilead Sciences to acquire MYR GmbH
Gilead to acquire Hepcludex, a first-in-class entry inhibitor, for treatment of chronic hepatitis delta virus (HDV), after closing…
EU drugs watchdog expects first application for COVID-19 vaccine in days
Europe’s drugs watchdog said on Thursday it expects to receive the first application for conditional marketing approval for a…
DCGI asks state drug controllers to recall ulipristal acetate tablets from market
The decision is based on the PRAC recommendations and reported cases of liver injury in the EU
Prestige Biopharma drug gets positive EMA opinion on Orphan Designation to treat pancreatic cancer
PBP1510 has already received ODD status from the US FDA in June 2020
EMA to review MAA for avalglucosidase alfa, enzyme replacement therapy to treat Pompe disease
The MHRA in the UK has granted Promising Innovative Medicine designation for avalglucosidase and US FDA has granted it…
EMA approves label update for Takeda’s HYQVIA, expands use to treat secondary immunodeficiencies
It was based on evidence from clinical trials that demonstrated that subcutaneous administration of immunoglobulin has been shown…
Rozlytrek from Roche gets EC approval to treat solid tumours and NSCLC
The approval is based on results from the integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I…
EMA finalises opinion on presence of nitrosamines in medicines
Companies will be required to have appropriate control strategies to prevent or limit the presence of these impurities and, where…
EMA launches public consultation on joint network strategy to 2025
Inputs can be submitted until September 4 via an online questionnaire