Innate Pharma SA (IPHA) announced that the FDA has granted Breakthrough Therapy Designation to lacutamab for treating adults ...

Pharm Exec’s 20th Annual Pipeline Report examines the emerging drug development trends and surging investments in five ...

Belgium’s Deputy Prime Minister, Frank Vandenbroucke, called the EU’s joint health technology assessment a model of European cooperation, improving medicine evaluation, reducing costs, and ...

New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.

The International Society for Pharmaceutical Engineering (ISPE) has announced planned featured speakers for the 2025 ISPE Aseptic Conference, taking place Monday, 17 March, through Tuesday, 18 March, ...

The rapid advancements in regenerative medicine (RM), including cell therapies, gene therapies, tissue-engineered products, and combined RM advanced therapies, require the development of regulatory ...

has provided a positive opinion for Advanced Therapy Medicinal Product (ATMP) classification for the company's gene therapy candidate OCU400 to treat Retinitis pigmentosa. A phase 3 study of ...

Ocugen, Inc. has announced that the European Commission has given a positive opinion for the classification of its gene therapy product, OCU400, as an Advanced Therapy Medicinal Product (ATMP) by ...

Jan. 29, 2025 /PRNewswire/ -- CPC (Colder Products Company), part of Dover ... designed to significantly simplify cell and gene therapy (CGT) closed sterile processing. "Cell and gene therapy ...

Cancer and chronic viral infections, for example, often exploit cellular mechanisms to suppress immune responses, making them formidable adversaries. This Patent Highlight explores two groundbreaking ...

has granted Regenerative Medicine Advanced Therapy (RMAT) designation to laru-zova (laruparetigene zovaparvovec) for the treatment of X-linked retinitis pigmentosa (XLRP). RMAT designation was ...