Tag : Food and Drug Administration

Clinical Research, Pharma & Healthcare Financing

Celltrion’s YUFLYMA® Receives FDA Interchangeability Designation

PR Newswire
by PR Newswire099
Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for YUFLYMA® (adalimumab-aaty), now including prefilled syringe (40mg)...
Clinical Research, Pharma & Healthcare Financing

Ascletis Announces FDA Clearance for ASC50 Psoriasis Trial

PR Newswire
by PR Newswire0117
ASC50 is an in-house discovered and developed oral small molecule interleukin-17 (IL-17) inhibitor for the treatment of multiple autoimmune and inflammatory diseases, including psoriasis. Following...
Healthcare Infrastructure, Operations & Supply Chain

Caliway Announces Successful EOP2 Meeting with FDA for CBL-514

PR Newswire
by PR Newswire0119
Caliway Biopharmaceuticals (TWSE: 6919) today announced the successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for CBL-514, the company’s proprietary...
Digital Health, Technology & Innovation

Caranx Medical Submits FDA Filing for TAVIPILOT Soft AI Software

Business Wire
by Business Wire0134
Caranx Medical (“Caranx”), a French medical device company specializing in the development of an autonomous robot to democratize access to Transcatheter Aortic Valve Implantation (TAVI),...