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

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 ...

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

Magdalena aiming to submit Investigational New Drug (IND) application in 2025 to the FDA for a next-generation psychoactive prescription drug candidate for potential mental health indications such as ...

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

Please provide your email address to receive an email when new articles are posted on ... episodes and nighttime blood pressure (BP). The drug’s safety profile in this specific patient ...

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

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug ...

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

Am J Health Syst Pharm. 2006;63(11):1022-1028. Q: How can potential medication errors be minimized when dispensing investigational drugs to better ensure patient safety and improve adherence to ...

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 ...