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NICE backs UCB drug as first uncontrolled gMG therapy

UCB's Rystiggo can be used by the NHS as a backup treatment for people with the rare autoimmune and neuromuscular disease gMG, says NICE.

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Norgine gets first EU approval for WHIM syndrome therapy

Patients in the EU with the ultra-rare disease WHIM syndrome now have their first approved treatment, Norgine's Xolremdi.

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GSK eyes October FDA verdict on chronic hep B drug

GSK's antisense-based drug for chronic hepatitis B (CHB), bepirovirsen, has started a speedy FDA review that should deliver a verdict by 26th October.

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FDA grants three priority vouchers to psychedelics

The FDA dropped a surprise Friday announcement that three more National Priority Vouchers would be given to a trio of psychedelics companies.

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FDA declines to approve AbbVie's Botox follow-up

AbbVie's bid to bring a rapid and shorter-acting botulinum toxin product to the US market has been knocked back by the FDA.

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FDA clears first genetic hearing loss gene therapy

Regeneron's Otarmeni is the first gene therapy for congenital hearing loss to be cleared by the FDA, and will be made available for free in the US.

NICE backs UCB drug as first uncontrolled gMG therapy

Norgine gets first EU approval for WHIM syndrome therapy

GSK eyes October FDA verdict on chronic hep B drug

FDA grants three priority vouchers to psychedelics

FDA declines to approve AbbVie's Botox follow-up

FDA clears first genetic hearing loss gene therapy

Parexel buys Vitrana to boost patient safety toolkit

Discover a new era of healthcare panel engagement: Grounded ...

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