Natera wins FDA Breakthrough Device status for multi-cancer blood test as NTRA climbs
Natera’s multi-cancer blood test wins FDA Breakthrough Device status after a 12-cancer review, but full performance data remain undisclosed.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
What RingConn’s FDA SpO2 clearance means for medical-grade wearable monitoring
RingConn's FDA-cleared blood oxygen ring marks a medical wearable milestone, but device scope and clinical adoption remain critical.
Pharma & Biotech
Teva wins FDA approval for Weltruza as monthly olanzapine changes schizophrenia LAI equation
Teva’s Weltruza wins FDA approval as a monthly subcutaneous olanzapine without loading doses, oral supplementation or post-injection monitoring.
Pharma & Biotech
Sling Therapeutics reports 82% sustained response with linsitinib in thyroid eye disease
Sling reports 82% sustained response among linsitinib responders after 48 weeks off therapy. See why Phase 3 ORBIT is the next critical test.
Medical Devices & Diagnostics
Asahi Kasei’s Hovilpri wins FDA approval after PRIOH-1 trial demonstrates superior lesion healing
FDA approves Hovilpri for refractory HSV after 63% lesion healing in Phase 3. See how pritelivir changes treatment and Asahi Kasei's outlook.
Pharma & Biotech
Roche Tecentriq FDA approval expands treatment for stage III dMMR colon cancer
FDA approval moves Tecentriq into adjuvant stage III dMMR colon cancer after ATOMIC showed a 50% reduction in recurrence or death risk.
Pharma & Biotech
How Rhapsido’s symptomatic dermographism approval expands Novartis immunology strategy
Novartis’ Rhapsido won the first FDA label for symptomatic dermographism after a 29.3% complete response in Phase 3 RemIND.
Pharma & Biotech
Roche cuts MS relapses up to 58.5% with fenebrutinib as FDA weighs an oral rival to its own Ocrevus
The FDA has accepted Roche’s fenebrutinib filing under Priority Review for both relapsing and primary progressive multiple sclerosis, potentially creating a high-efficacy oral alternative across disease forms currently treated very differently.
Pharma & Biotech
Eli Lilly just cut basal insulin dosing from 365 injections to 52. Can Onswik catch Novo Nordisk’s Awiqli?
Eli Lilly and Company has secured U.S. Food and Drug Administration approval for Onswik, its once-weekly basal insulin for adults with type 2 diabetes, bringing a second weekly insulin into the U.S. market and shifting the competitive question from regulatory feasibility to prescribing, access and real-world adoption.
Pharma & Biotech
Prime Medicine stock jumps after FDA clears PM647 gene-editing trial for alpha-1 antitrypsin deficiency
Prime Medicine shares jumped in after-hours trading after the FDA cleared PM647 for first-in-human testing, moving a one-time gene-editing therapy for alpha-1 antitrypsin deficiency from promising animal data into the much harder test of clinical development.