Keyword: European Commission
Ebola has claimed thousands of lives in recent outbreaks, but now the world has a licensed vaccine option in Merck's Ervebo.
Roche’s Tecentriq is on a roll in Europe. After picking up a green light in breast cancer last week, it's now snagged a pair of go-aheads in lung cancer.
In March, Roche’s Tecentriq led its class into the triple-negative breast cancer arena with an FDA nod. Now, it’s done the same across the pond.
Sanofi and Regeneron’s Libtayo is two for two in the last two days—at winning over key European regulatory and reimbursement bodies, that is.
The new endorsement of Celgene's Revlimid from England's cost watchdog NICE may not help calm fears about BMS' $74 billion buyout.
Stymied by an FDA rejection last year, Ionis and Akcea’s Waylivra seemed doomed. Fortunately, the ultrarare disease drug found new life in Europe.
After a tough year in the competitive MS field, Sanofi’s Lemtrada could hardly afford another setback. But that’s exactly what it got.
The EU approval is conditional on selling off a Shire experimental IBD drug, which Takeda said could attract "a number of potential buyers."
Amid reports that it will sell Shire's Xiidra and Natpara, Takeda said it may sell SHP647, a phase 3 bowel drug that would overlap its own Entyvio.
The entry of a fifth biosimilar rival to Humira in Europe could feed fears of a bigger-than-predicted impact on AbbVie.