Browsing Tag
U.S. Food and Drug Administration
166 posts
Immutep (NASDAQ: IMMP) jumps 15% as efti review points to manufacturing differences
Immutep has identified potentially relevant structural differences between 200-litre and 2,000-litre efti manufacturing batches after the TACTI-004 failure, prompting a return to 200-litre production and a narrower clinical strategy.
uniQure files AMT-130 in U.S. and U.K. as Huntington’s gene therapy reaches regulators
uniQure has submitted AMT-130 for accelerated U.S. approval and filed simultaneously in the United Kingdom, moving the Huntington’s gene therapy from regulatory planning into formal review.
Bubs Australia (ASX: BUB) wins permanent US FDA approval as shares jump 35%
Bubs Australia Limited has secured permanent U.S. FDA authorisation for Bubs Goat, Bubs 365 Day Grass Fed and Bubs Essential infant formulas, replacing the temporary regulatory pathway that supported its expansion into more than 10,000 U.S. stores.
Conavi’s FDA-cleared Novasight heads for U.S. hospitals after emergency-like financing
Conavi Medical ended June with only C$0.9 million of cash before raising C$10 million to fund the U.S. launch of its FDA-cleared next-generation Novasight Hybrid IVUS-OCT coronary imaging system.
Elecsys pTau217 wins FDA clearance as Roche pushes Alzheimer’s testing into primary care
Roche has secured FDA clearance for Elecsys pTau217, giving more than 4,500 existing U.S. cobas analyzers a potential role in assessing Alzheimer’s amyloid pathology through a routine blood draw.
Abbott’s Libre Duo wins FDA De Novo as glucose monitoring expands into ketones
Abbott has secured FDA De Novo authorization for Libre Duo 10 Day, creating the first U.S. wearable category that continuously monitors both glucose and ketones from a single sensor.
Revolution Medicines wins FDA approval for Rasonque after 60% reduction in death risk
The FDA has approved Revolution Medicines’ Rasonque for previously treated metastatic pancreatic adenocarcinoma after a Phase 3 trial showed median overall survival of 13.2 months versus 6.7 months with chemotherapy.
Ziihera FDA approval unlocks $250m for Zymeworks as Jazz expands HER2 drug into first-line gastric cancer
The FDA has approved two Ziihera-based first-line regimens for HER2-positive advanced gastroesophageal adenocarcinoma, triggering a $250 million payment to Zymeworks and giving Jazz a much larger commercial opportunity.
Sight Sciences wins broader TearCare label as dry eye revenue jumps 704%
Sight Sciences has secured an expanded FDA indication stating that TearCare improves meibomian gland function, strengthening the clinical positioning of a dry-eye business that grew more than sevenfold year on year in the second quarter.
Scholar Rock keeps apitegromab FDA decision alive as Europe filing is reset
Scholar Rock has removed Catalent Indiana from the U.S. apitegromab application while keeping its September 30 FDA decision date intact, but the manufacturing issue has forced a European filing withdrawal and resubmission.