Browsing Tag
FDA
293 posts
MiRus earns NTAP approval for EUROPA cervical fusion system, expanding clinical and reimbursement footprint
MiRus receives CMS NTAP approval for its EUROPA Posterior Cervical Fusion System, boosting adoption and access for Medicare patients with spine disorders.
How the White House’s AI push is reshaping healthcare stocks like Avant Technologies and GE HealthCare
Avant Technologies and Ainnova Tech take Vision AI closer to FDA approval as White House backs AI in healthcare with regulatory sandboxes and pilot incentives.
Modella AI and illumiSonics validate generative AI and virtual H&E integration for stain-free digital pathology
Modella AI and illumiSonics validate a breakthrough in virtual H&E and generative AI compatibility, advancing fully digital, stain-free pathology diagnostics.
Bayer’s FDA review extension for elinzanetant signals global push for hormone-free menopause therapies
Bayer receives FDA review extension for elinzanetant menopause drug; U.S. approval still likely, with global rollout underway and analysts optimistic.
Shanton Pharma’s SAP-001 earns FDA Fast Track status for refractory gout treatment
FDA grants Fast Track designation to Shanton Pharma’s SAP-001 for refractory gout; company plans accelerated development and Phase 3 trials.
Genentech’s Columvi combo fails to secure FDA approval for second-line DLBCL use
FDA rejects Genentech’s sBLA for Columvi-GemOx in second-line DLBCL treatment; survival benefit data deemed insufficient for U.S. approval.
Sarepta Therapeutics halts ELEVIDYS shipments for non-ambulatory Duchenne patients as FDA demands enhanced safety measures
Sarepta Therapeutics halts ELEVIDYS shipments for non-ambulatory Duchenne patients amid FDA liver safety review; analysts assess market risks and future outlook.
Genentech faces FDA setback for Columvi GemOx in second-line diffuse large B-cell lymphoma as SKYGLO trial becomes key to future U.S. expansion
Genentech’s Columvi GemOx sBLA faces FDA rejection in second-line DLBCL. Analysts await SKYGLO trial data for U.S. approval prospects. Learn more.
FDA approves Cerapedics’ PearlMatrix as first proven bone growth accelerator for lumbar spinal fusion
FDA approves Cerapedics' PearlMatrix™ bone graft for lumbar fusion; ASPIRE study confirms faster spinal healing in high-risk patients.
Lumos Diagnostics (ASX: LDX) reaches 500-patient milestone in FebriDx CLIA study
Lumos Diagnostics hits a key 500-patient milestone in its FebriDx CLIA waiver study, triggering BARDA funds. FDA application expected by October 2025.