Browsing Tag
FDA
293 posts
Supernus wins FDA approval for ONAPGO, a continuous infusion therapy for Parkinson’s disease
The U.S. Food and Drug Administration (FDA) has granted approval to Supernus Pharmaceuticals, Inc. for ONAPGO (apomorphine hydrochloride)…
Roche secures FDA approval for HER2-ultralow metastatic breast cancer diagnostic
Roche has received FDA approval for an expanded use of its PATHWAY HER2 (4B5) test, marking a significant…
Wockhardt’s Zaynich achieves record-breaking 96.8% clinical cure rate in cUTI Phase III trial
Wockhardt Limited has announced a major breakthrough in the treatment of complicated urinary tract infections (cUTI) with its…
FDA approves Leqembi maintenance dosing for early Alzheimer’s treatment
The U.S. Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for Leqembi (lecanemab-irmb), an…
Amylyx Pharmaceuticals resumes AMX0114 clinical trials for ALS after FDA clears path
Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) has announced that the U.S. Food and Drug Administration (FDA) has lifted the…
Arrowhead Pharmaceuticals advances plozasiran for familial chylomicronemia syndrome with FDA NDA acceptance
Arrowhead Pharmaceuticals, Inc. has taken a major step toward addressing a critical gap in rare disease treatment. The…
Datroway approved in US: A new era in metastatic breast cancer treatment
In a landmark decision, the US Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan), a first-in-class…
FDA approves ZYN nicotine pouches: A milestone in safer smoking alternatives
The U.S. Food and Drug Administration (FDA) has taken a significant step by authorizing ZYN nicotine pouches, produced…
Tempus AI stock soars 14% after FDA approval of xT CDx test
Tempus AI, a leader in healthcare technology, has unveiled its FDA-approved in vitro diagnostic device, xT CDx, marking…
Firefly Neuroscience’s BNA platform unlocks early Alzheimer’s screening potential
Firefly Neuroscience, Inc., a prominent artificial intelligence company focused on brain health innovation, has announced a groundbreaking advancement…