regulatory

News

Eisai, Biogen eye 2025 approval for Leqembi autoinjector

Eisai and Biogen have completed their rolling biologics license application in the US for a subcutaneous formulation of Alzheimer's disease therapy Leqembi previously delayed by the FDA on

Oncology

Juggling CMC trade-offs with personalised cancer vaccines

Personalised cancer vaccines offer significant potential to address an unmet medical need in treatment-resistant disease with fewer side effects and less toxicity compared to standard treat

News

winking smiley face on paper held in front of a woman's face

Astellas pulls geographic atrophy drug filing in the EU

Astellas confirmed today that it will withdraw its EMA filing for avacincaptad pegol as a treatment for eye disorder geographic atrophy (GA), based on feedback from the EU regulator.

News

AZ, Ionis get CHMP backing for ATTR polyneuropathy drug

AstraZeneca and Ionis are set fair for EU approval of Wainzua, their treatment for polyneuropathy associated with transthyretin-mediated amyloidosis (ATTR), after the EMA's human medicines

News

Novo Nordisk closes on EU okay for haemophilia antibody

Novo Nordisk's anti-TFPI antibody concizumab has been backed for approval in the EU as a once-daily drug to prevent bleeding episodes in people with haemophilia.

News

Australia joins EU in turning down Alzheimer's drug Leqembi

Australia's Therapeutic Goods Administration (TGA) has said it won't approve Eisai and Biogen's Alzheimer's disease therapy Leqembi, saying its efficacy does not outweigh its risks.

Eisai, Biogen eye 2025 approval for Leqembi autoinjector

Juggling CMC trade-offs with personalised cancer vaccines

Astellas pulls geographic atrophy drug filing in the EU

AZ, Ionis get CHMP backing for ATTR polyneuropathy drug

Novo Nordisk closes on EU okay for haemophilia antibody

Australia joins EU in turning down Alzheimer's drug Leqembi

Eisai debuts biliary tract cancer drug in Japan

Coming soon: The Life Sciences Industry Report 2025 – insigh...

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