Greater transparency in FDA decision-making was possibly the most common theme for stakeholders interviewed by the Institute ...

Medera Inc. ("Medera"), a clinical-stage biopharmaceutical company developing next-generation cardiovascular therapeutics, and its clinical development division Sardocor, today announced that the U.S.

OPN-6602 Currently Treating Patients in Phase 1 Clinical Trial SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--April 15, 2026-- Opna Bio, a clinical-s ...

Arbutus Biopharma Corporation (NASDAQ:ABUS) shares climbed 6% on Wednesday after the company revealed it had received Fast ...

The FDA has granted Fast Track designation to KT-621, a first-in-class oral STAT6 degrader for moderate to severe ...

Arbutus Biopharma has won U.S. Food and Drug Administration fast-track designation for its proposed imdusiran treatment for chronic hepatitis B, a serious liver infection. The Warminster, Pa., ...

Fast Track designation has the potential to facilitate development and accelerate FDA review of imdusiran WARMINSTER, Pa., April 15, 2026 ...

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases ...

Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today announced the ...

Recce is developing a new class of antibiotics to tackle drug-resistant superbugs almost a century after the development of ...

Fast Track status enables closer FDA engagement to potentially accelerate development of a CDH6-directed ADC in ...

The FDA has granted fast track and rolling review status to Celltrion’s CT-P71, a Nectin-4 targeting ADC for treating ...