Results from the NOVA study show every six-week dosing with natalizumab is as effective as every four-week in relapsing-remitting MS.
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NaviFUS® was approved by the Taiwan FDA for use in a new clinical trial for the treatment of terminal primary brain tumours.
New data shows Lilly’s Olumiant (baricitinib) significantly reduces the risk of death in hospitalised COVID-19 patients receiving invasive mechanical ventilation or ECMO.
H1 financial results show AstraZeneca’s revenues grew by 23 percent in 2021, with $14.37 billion attributed to activities aside from COVID-19 vaccine sales.
A new approach to the cost-comparison fast-track appraisal process is being piloted this summer for the review of low-risk appraisals.
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original New Drug Application (NDAs) and Biological License Application (BLAs) are expected to be submitted to FDA, in accordance with The FDA Reauthorization Act (FDARA).
Live biotherapeutic products (LBPs) are expected to help patients with IBS who currently have no US- or EMA-approved treatments.
US President announces $60 million in funding to support domestic API production and a consortium to onshore essential medicine manufacturing.
The company’s second quarter (Q2) results reveal a $9.1 billion increase in revenues from Q2 2020 and significant operational growth.
Phase II trial results suggest Daewoong Pharmaceutical’s Foistar (Camostat mesilate) may significantly expedite recovery from mild COVID-19 symptoms.
A collaborative project will develop automated manufacturing controls for biologics such as antibodies, viral vectors and vaccines.
The Phase II study of Evrysdi showed significant improvements in survival and motor milestones in babies with type 1 spinal muscular atrophy (SMA).
The first interchangeable biosimilar insulin product will help increase access and affordability of insulin for diabetics.