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- PMLiVE

Diabeloop’s DBLG2 receives FDA and CE clearance for automated insulin delivery without meal input

While a lack of meal announcements can lead to lower glycaemic control, it reduces the mental burden for those with type 1 diabetes

- PMLiVE

BMS acquires Orbital Therapeutics in $1.5bn deal

The deal includes several next-gen cell therapy candidates for autoimmune diseases

- PMLiVE

FDA unveils new voucher programme to accelerate drug review process

The programme is designed to reduce the review time for companies supporting US national interests

- PMLiVE

FDA approves Bavarian Nordic’s chikungunya vaccine for individuals aged from 12 years

The mosquito-borne viral disease has been reported across many popular travel destinations

- PMLiVE

Roche’s Evrysdi tablet formulation granted FDA approval for spinal muscular atrophy

The progressive neuromuscular disease affects approximately one in every 10,000 babies globally

- PMLiVE

FDA accepts updated protocol for Annovis’ phase 3 Alzheimer’s disease study

The company hopes the revised protocol will accelerate the development timeline of buntanetap

- PMLiVE

Roche expands cell therapy capabilities with $1.5bn Poseida acquisition

The deal includes a BCMA-targeting allogeneic CAR-T therapy candidate for multiple myeloma

- PMLiVE

AstraZeneca announces $3.5bn US investment to boost research and manufacturing

The commitment is part of the company’s ambition to achieve $80bn in total revenue by 2030

- PMLiVE

FDA approves BridgeBio Pharma’s Attruby to treat rare heart disease ATTR-CM

Transthyretin amyloid cardiomyopathy affects up to 500,000 people worldwide

- PMLiVE

UCB’s Bimzelx granted FDA approval to treat hidradenitis suppurativa in adults

The inflammatory skin disease affects approximately one in every 100 people in the US

- PMLiVE

Novavax announces FDA clinical hold lift on phase 3 COVID-19/flu vaccine study

The serious adverse event reported was found to be unrelated to the vaccine

- PMLiVE

FDA approves Autolus Therapeutics’ Aucatzyl to treat acute lymphoblastic leukaemia

Approximately 8,400 adults are diagnosed with the aggressive blood cancer every year in the US and EU

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