This move comes a day after President Trump signed an executive order to streamline approval processes for domestic plants.

At a time when investment has been low in biotech, establishing and maintaining good relationships with investors is vital.

The US FDA has granted regenerative medicine advanced therapy (RMAT) designation to Opus Genetics’ gene therapy OPGx-LCA5 ...

Novo Nordisk has cut its sales and profits forecasts for 2025 due to lower demand in the US for blockbuster weight loss and ...

Sarepta’s stock dropped by 26% after the FDA named a vocal critic of its gene therapy programme to lead its biologics ...

Venture philanthropy organisation Solve FSHD has announced an investment of $3m in Armatus Bio to support the development of ...

Discussing AstraZeneca’s experience with the Project Orbis pathway, Sabine Ledderhose, head of regulatory affairs for the ...

The European Commission (EC) has approved AstraZeneca's Bruton's tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) ...