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.

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 ...

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

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

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

The mRNA therapeutics field is rapidly evolving beyond vaccines to include treatments for cancer, genetic disorders and in vivo cell therapies, bringing with it diverse production challenges. As the ...

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

Artificial intelligence (AI) should soon be taking a greater role in areas including patient recruitment and in building efficiencies around data quality.

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

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