regulatory approval

News

Novavax gets green light for updated COVID vaccine

Novavax has been given the go-ahead by regulators in the US for an updated version of its COVID-19 vaccine that targets the XBB.1.5 variant of the coronavirus.

News

Biogen claims first with FDA nod for biosimilar Actemra

Biogen says it is the first drugmaker in the US to get FDA approval for a biosimilar of Roche’s $3 billion blockbuster product Actemra.

News

Leqembi approved in Japan, its first ex-US market

Eisai and Biogen now have their second regulatory approval for anti-amyloid therapy Leqembi – in Japan – as a treatment for slowing the progression of Alzheimer’s disease.

News

Menarini brings oral SERD to Europe with Orserdu okay

Menarini has secured EU approval for Orserdu, the first in a new class of oral selective oestrogen receptor degrader (SERD) drugs and the first innovation in endocrine the

News

EU has its first RoActemra biosimilar, from Fresenius Kabi

The European Commission has approved the first biosimilar version of Actemra/RoActemra, Roche’s $3 billion blockbuster, from German drugmaker Fresenius Kabi.

News

GSK gets wide FDA approval for myelofibrosis drug

GSK's cancer unit has been given a fillip by the FDA with a broader-than-expected approval for JAK inhibitor momelotinib for anaemia associated with myelofibrosis, acquire

Novavax gets green light for updated COVID vaccine

Biogen claims first with FDA nod for biosimilar Actemra

Leqembi approved in Japan, its first ex-US market

Menarini brings oral SERD to Europe with Orserdu okay

EU has its first RoActemra biosimilar, from Fresenius Kabi

GSK gets wide FDA approval for myelofibrosis drug

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

regulatory approval

Editor's Picks