Broad label FDA approval for phenylketonuria drug
Alongside Phase III data demonstrating significant efficacy in the rare disease, the FDA’s decision could position the small molecule as a future standard of care.
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Alongside Phase III data demonstrating significant efficacy in the rare disease, the FDA’s decision could position the small molecule as a future standard of care.
The new findings support a limited duration dosing approach and highlight the consistent safety profile for Eli Lilly’s antibody drug.
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
The landmark regulation establishes a future where highly personalised treatments are part of routine care, says MHRA’s Chief Executive.
The new deal could support innovation of next-generation combination vaccines to protect older adults against multiple respiratory viruses.
The MHRA's approval provides eligible patients with a novel delivery method that is convenient and non-invasive.
Recommendation of the once-daily triple therapy increases the number of eligible cystic fibrosis patients who can access treatments in the UK.
The pharmaceutical industry faces mounting pressure to modernise its testing methods, driven by concerns over animal welfare, sustainability, and the need for more reliable results. Following a recent webinar, Fujifilm Wako discusses its Pyrostar™ Neo+ reagent and reveals how recombinant technology is transforming endotoxin testing while addressing evolving industry demands.
Based on the clinical trial results, the drugs could particularly benefit tuberculosis patients requiring extended therapeutic intervention.
The US drug agency’s authorisation provides hereditary angioedema (HAE) patients with the first new on-demand treatment in over ten years.
The study represents the first time the injectable gene therapy has been evaluated in teenagers and adults.
The EU authorisation offers a new treatment option for acromegaly, providing effective disease control and enabling convenient self-administration.
The new acquisition, worth up to $2.1 billion, gives AbbVie rights to a potential first-in-class drug for B cell-mediated autoimmune diseases.
The investigational dual-targeting treatment provided strong and durable delivery to tumours, allowing for a high dose of targeted radiation, early results show.
EPR Issue 2 includes articles on the impact of tariffs on the pharmaceutical supply chain, advances in bioprocessing, manufacturing and more.