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- 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

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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

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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

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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

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

Transthyretin amyloid cardiomyopathy affects up to 500,000 people worldwide

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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

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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

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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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FDA approves Journey Medical’s Emrosi to treat inflammatory lesions of rosacea

The long-term skin condition affects more than 16 million people in the US

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Novartis’ Scemblix granted FDA accelerated approval in newly diagnosed CML

Approximately 9,280 new cases of the disease are expected to be diagnosed in the US this year

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Astellas’ Vyloy approved by FDA as first-line gastric cancer combination treatment

Approximately 26,890 new cases of gastric cancer will be diagnosed in the US this year

- PMLiVE

AbbVie’s continuous Parkinson’s disease therapy Vyalev approved by FDA

More than ten million people worldwide are living with the neurological disorder

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