In a recent webinar, industry experts explain how real-world data and patient-centric support can shape regulatory success ...

The FDA has issued more than 200 complete response letters, which detail reasons for non-approval of drug applications.

The DoH and Children’s National Hospital in the US have signed a MoU to advance paediatric cell and gene therapy.

IGI Therapeutics has signed an exclusive licensing agreement with AbbVie, for ISB 2001 to treat cancer and autoimmune diseases.

With clinical trials under pressure, industry leaders say it’s time for reform, digital transformation, and more patient-centric models.

Achieving good oral bioavailability for targeted protein degraders (TPDs) is vital in providing a patient-friendly way to ...

Proposals for drug exclusivities and feeble measures to combat drug shortages are unlikely to boost innovation, say some ...

Zentiva Group has entered a licence and supply agreement with Lupin for the commercialisation of latter’s biosimilar Certolizumab Pegol.

Merck has entered a definitive agreement to acquire biopharmaceutical company Verona Pharma in a deal valued at $10bn.

Transcend Therapeutics announced that the FDA has granted breakthrough therapy designation to TSND-201 to treat PTSD.

JCR Pharmaceuticals has signed a licence agreement with Alexion, AstraZeneca Rare Disease, for its proprietary JUST-AAV capsids.

The US dominates overall sales, yet GlobalData predicts that China is shaping up to be a formidable presence in the cell therapy space.