Browsing Tag
U.S. Food and Drug Administration
151 posts
Jazz Pharmaceuticals closes $820m Actio Biosciences deal to deepen epilepsy pipeline
Jazz Pharmaceuticals buys Actio Biosciences for $820 million upfront, betting on ABS-1230 while early-stage clinical risk remains the key test.
Telix wins Pixclara approval as first U.S. FET-PET agent opens brain cancer market
Telix has secured FDA approval for Pixclara, the first U.S.-approved FET-PET imaging drug for glioma, converting a 2025 Complete Response Letter into a new brain-cancer diagnostics franchise.
LUMA Vision clears FDA hurdle as VERAFEYE targets an early 2027 U.S. launch
LUMA Vision has secured expanded FDA clearance for VERAFEYE, combining real-time 3D cardiac anatomy, catheter tracking and ablation guidance ahead of a planned commercial launch in early 2027.
Scholar Rock (NASDAQ: SRRK) wins FDA approval for ISEMBYLD in spinal muscular atrophy
Scholar Rock has secured its first U.S. Food and Drug Administration approval with ISEMBYLD, moving from a pre-revenue biotechnology company into commercial execution as analysts model a multibillion-dollar opportunity in spinal muscular atrophy.
Bayesian Health clears the reimbursement hurdle after FDA win for continuous sepsis AI
Bayesian Health has secured Medicare NTAP reimbursement for its FDA-cleared sepsis monitoring software across roughly 739 inpatient DRGs, but the maximum additional payment is only $61.84 per eligible discharge.
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.