Browsing Tag
United States Food and Drug Administration
192 posts
Telix Pharmaceuticals wins FDA Fast Track for BiPASS as prostate imaging moves before biopsy
Telix Pharmaceuticals Limited has received FDA Fast Track designation for its BiPASS programme, advancing a strategy that combines PSMA-PET and MRI before prostate biopsy as the company prepares a planned US regulatory submission.
uniQure shares tumble as Huntington’s gene therapy shows weaker four-year cUHDRS benefit
uniQure shares plunge as four-year ifezuntirgene data show mixed Huntington’s results while the gene therapy awaits FDA review.
DEGEVMA approval strengthens Teva biosimilar pipeline as company shifts beyond traditional generics
Teva wins FDA approval for DEGEVMA, expanding its U.S. denosumab biosimilar portfolio as competition intensifies around Xgeva.
Joenja moves closer to broader pediatric APDS label as Pharming Group builds second growth franchise
Pharming Group wins FDA Priority Review for lower-dose Joenja in children with APDS as the fast-growing rare-disease franchise expands.
Efzofitimod returns to pivotal development as aTyr Pharma targets narrower sarcoidosis population
aTyr Pharma gains FDA alignment for a redesigned efzofitimod Phase 3 trial, but financing and clinical validation remain major hurdles.
Kyverna Therapeutics targets autoimmune CAR T breakthrough after durable miv-cel results
Kyverna Therapeutics reports durable one-year miv-cel results in stiff person syndrome as its rolling FDA filing moves toward completion.
Sefaxersen moves toward regulatory talks after Roche delivers positive Phase III IgAN result
Roche’s sefaxersen hits its Phase III IgAN endpoint as the company eyes regulatory talks in a fast-growing kidney disease market.
Mesoblast rises as FDA clears new commercial potency assay for Ryoncil
Mesoblast Limited shares rose after the United States Food and Drug Administration approved an additional potency assay for commercial Ryoncil manufacturing, strengthening quality controls as the Australian biotechnology company scales its first marketed cell therapy.
FDA approves Eli Lilly’s Inluriyo-Verzenio combination for ESR1-mutated breast cancer
The United States Food and Drug Administration has approved Inluriyo with Verzenio for a genetically defined form of advanced breast cancer after endocrine therapy. In a 159-patient analysis, median progression-free survival reached 11.1 months with the combination versus 5.5 months with Inluriyo alone, expanding Eli Lilly's ability to pair two medicines from its own oncology portfolio.
Retatrutide development: Phase 3 results, 2027 FDA filing, TRIUMPH trials and what comes next
Eli Lilly and Company’s retatrutide programme has completed the core Phase 3 clinical package supporting planned submissions for obesity, knee osteoarthritis pain and obstructive sleep apnea. The investigational triple hormone receptor agonist is moving toward a U.S. filing in the first quarter of 2027 while additional studies test diabetes, cardiovascular and kidney outcomes, liver disease, chronic pain, maintenance treatment and its performance against tirzepatide.