Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) and rare paediatric disease designation ...

A nasal vaccine for COVID-19 – based on technology developed at Washington University in St. Louis – is poised to enter a ...

On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...

Celltrion launches ADC cancer drug trials in U.S. while planning additional INDs Celltrion accelerates its global drug ...

today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) to initiate a clinical study of the company’s investigational UKidney ...

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application ...

Affinia Therapeutics, a gene therapy company with a pipeline of adeno-associated virus (AAV) gene therapies for devastating ...

In 2022, Congress passed the FDAMA 2.0, which Kennedy helped introduce and Pres. Joe Biden signed into law. The law removes a ...

Veteran scientist Hideo Makimura, M.D., Ph.D., is going fully preclinical by joining gene therapy biotech Affinia ...

Ultragenyx Pharmaceutical RARE reported new findings from an ongoing, pivotal study of its investigational candidate, UX111 (ABO-102) AAV gene therapy, for Sanfilippo syndrome type A (MPS IIIA). Per ...