Harm Reduction Therapeutics
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
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
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
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
FDA approves BridgeBio Pharma’s Attruby to treat rare heart disease ATTR-CM
Transthyretin amyloid cardiomyopathy affects up to 500,000 people worldwide
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
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
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
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
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
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
AbbVie’s continuous Parkinson’s disease therapy Vyalev approved by FDA
More than ten million people worldwide are living with the neurological disorder