Iovance Biotherapeutics, Inc.

The US Food and Drug Administration’s expectations for the timing of accelerated approval confirmatory trials came into clearer focus in 2024 with new policy documents and real-world examples. The age

Seven new advanced therapy medicinal products (ATMPs) could be approved for pan-EU approval this year, based on data from the Pink Sheet’s EU regulatory filings tracker , including Roche / Sarepta

With a growing number of complex cell and gene therapies approved globally, mostly for rare disease populations, manufacturers are looking at how to make these products more accessible by delivering a

Immatics N.V. ’s lead T-cell receptor (TCR) therapy candidate, IMA203, is two months away from entering Phase III development as the company announced positive Phase Ib data in metastatic melanoma. Th