DHA R&D-MRDC researchers are applying the latest regulatory guidance related to AI to better carry out their mission to develop life-saving medicines.

Summit and Akeso report Phase 3 success as ivonescimab shows PFS gains in NSCLC trial, with new studies and collaborations underway.

Medical device makers must balance PFAS performance benefits with health risks, preparing for regulation by auditing ...

The bone graft incorporating rhBMP-2 has received FDA IDE approval for a pivotal clinical trial in spinal fusion ...

Atraverse Medical, a San Diego-based medical device company pioneering universally-compatible transseptal access technology, announced today that the latest clinical evidence on the efficacy and ...

EAGLE-1 trial data shows gepotidacin’s potential in treating gonorrhoea, for which no new antibiotics have been approved ...

Epiminder has received FDA authorisation through the De Novo classification for its implantable continuous EEG monitoring ...

The global peripheral vascular devices market, valued at USD 4.7 billion in 2022, is projected to expand at a robust CAGR of 6.6%, reaching USD 8.9 billion by 2032, according to Future Market Insights ...

Short Summary The EU, UK, and USA each have distinct and evolving regulatory systems for medicines and medical devices, involving strict approval, surveillance, and market access requirements managed ...