The US agency proposes its new regulatory framework will holistically address the unique challenges of rare disease drug ...
Merck KGaA is acquiring biotechnology company Silence Therapeutics for approximately $1.3 billion, a move that is set to ...
US approval of UCB's Zilbrysq provides a second self-administration option for AChR antibody-positive patients with the rare ...
When a nitrosamine drug substance-related impurity (NDSRI) is newly identified or increases above established control levels, ...
Sanofi has broken ground on a new, advanced insulin manufacturing facility at its BioCampus in Frankfurt, Germany, laying the ...
The EMA's human medicines committee's positive opinion is based on data showing the oral therapy reduced the risk of death by ...
Ability to nearly completely inhibit TYK2 pathway biomarkers positions SUN-627 as potential novel treatment for progressive forms of multiple sclerosis, according to Phase I data.
Agreement targets RNAi therapy with a unique mechanism that distinguishes itself in the increasingly crowded incretin therapy landscape for obesity and metabolic disease.
Collaboration will implement modelling and evidence generation to evaluate the use of artificial intelligence (AI) in clinical development and accelerate medicine access. Boehringer Ingelheim and ...
As clinical trials grow more complex, evidence of principal investigator oversight requires a more modern, risk-proportionate approach to demonstrate application of clinical and scientific judgment ...
As AAV therapies move beyond rare disease indications, manufacturing scalability becomes critical. Learn how an integrated approach to process development can help reduce risk, improve yields, and ...
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