regulatory

News

Disc maps out US filing for porphyria drug bitopertin

Disc Medicine has charted a route to market for bitopertin, its drug candidate for rare disease erythropoietic protoporphyria (EPP), after meeting with the FDA.

News

Lexicon's type 1 diabetes drug voted down by FDA adcomm

It has been five years since Lexicon Pharma's type 1 diabetes therapy, Zynquista, was rejected by the FDA, and it may struggle to have a better outcome at its second attempt.

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

Disc maps out US filing for porphyria drug bitopertin

Lexicon's type 1 diabetes drug voted down by FDA adcomm

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

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

regulatory

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