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U.S. FDA

GIE Medical Granted FDA’s Breakthrough Device Designation for Multi-Stage Drug Coated Balloon to Treat Esophageal Strictures

GIE Medical, a clinical stage company developing solutions for patients suffering from benign stricture(s) of the esophagus or bowel, was granted designation as a...

Legend Biotech Announces Submission of Supplemental Application to the U.S. FDA for Expanded Use of CARVYKTI

Legend Biotech Corporation, a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced the submission of a supplemental Biologics...

U.S. FDA Approves ABRYSVO, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO, the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the...

Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI for the Treatment of Agitation Associated with...

Otsuka Pharmaceutical Development & Commercialization, Inc, and Lundbeck Pharmaceuticals LLC announce the Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and...

Lumendi Receives 510(k) Clearance for Two New Devices

Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable...
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