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- PMLiVE

MHRA approves LEO Pharma’s Adtralza for adolescent patients with atopic dermatitis

The changes to the terms were also approved by the EC in October

regeneron headquarters

Regeneron’s Libtayo granted EC approval for recurrent or metastatic cervical cancer

A phase 3 trial demonstrated a 31% reduction in the risk of death compared to chemotherapy

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AbbVie’s Skyrizi receives EC approval for active Crohn’s disease

The approval makes Skyrizi the first specific IL-23 inhibitor as a Crohn's treatment in the EU

- PMLiVE

BeiGene’s Brukinsa receives EC approval for chronic lymphocytic leukaemia

The drug showed better results than Imbruvica, a current standard of care treatment

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Sanofi’s Enjaymo receives EC approval for rare autoimmune haemolytic anaemia

Cold agglutinin disease affects around 12,000 people in the US, Europe and Japan

regeneron headquarters

Regeneron’s Libtayo combination granted FDA approval for non-small-cell lung cancer

The decision was based on superior survival outcomes of Libtayo plus chemotherapy

- PMLiVE

AstraZeneca/Sanofi’s Beyfortus receives EC approval for prevention of RSV in infants

The decision makes the antibody the first broadly protective option for this age population

- PMLiVE

BeiGene’s Brukinsa receives EC approval for marginal zone lymphoma

The BTK inhibitor was also granted an additional year of marketing protection

- PMLiVE

Kite’s CAR-T therapy Yescarta granted EC approval in second-line lymphoma

The decision is based on results from the phase 2 ZUMA-7 study

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BeiGene’s Brukinsa receives CHMP recommendation for chronic lymphocytic leukaemia

CLL accounts for around one-quarter of new leukaemia cases

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EC approves Alexion’s Ultomiris as generalised myasthenia gravis treatment

The positive phase 3 trial results assessing the treatment were published in NEJM Evidence

- PMLiVE

AstraZeneca’s Tezspire receives EC approval as severe asthma add-on treatment

Tezspire demonstrated superiority across every primary and key secondary endpoint compared to placebo

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