EMA begins evaluation of data on Comirnaty booster dose
EMA’s human medicines committee (CHMP) is expected to undertake an accelerated assessment of data submitted by Pfizer and…
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07 Sep 21
EMA’s human medicines committee (CHMP) is expected to undertake an accelerated assessment of data submitted by Pfizer and…
02 Sep 21
The US FDA approval of Brukinsa was based on results from the Phase 3 ASPEN trial, which evaluated…
30 Aug 21
The EC approval is based on data from the vosoritide clinical development programme, including results from the Phase…
27 Aug 21
The drug was already approved in the US and the European Union for the treatment of CKD in…
27 Aug 21
The court ruled that certain parts of the patent were invalid and that the earlier jury verdict was…
26 Aug 21
According to the Phase 3 data, a booster dose of Comirnaty elicited significant immune responses, with a favourable…
24 Aug 21
Comirnaty is said to be the first Covid-19 vaccine to receive full FDA approval and is indicated to…
23 Aug 21
Zydus claims that its ZyCoV-D is the world's first plasmid DNA vaccine for Covid-19, with well-established safety, efficacy…
20 Aug 21
The EC approval for Abecma is based KarMMa trial, which showed rapid, deep and durable responses with a…
19 Aug 21
The US FDA approved Jardiance based on results from the Phase 3 EMPEROR-Reduced trial, in which the drug…