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
Pharma & Biotech
Hovilpri healed 63% of refractory HSV lesions by Day 28. Can Asahi Kasei build a $400 million franchise?
FDA approves Hovilpri for refractory HSV in immunocompromised adults after Phase 3 pritelivir beat investigator-choice therapy on lesion healing.
Medical Devices & Diagnostics
Why the Perceptive Discovery and Nucleus RadioPharma agreement matters for oncology drug development
Perceptive Discovery and Nucleus RadioPharma link imaging and manufacturing to address critical bottlenecks in radiopharmaceutical development.
Pharma & Biotech
UCB is committing $2bn to a U.S. biologics campus. The bigger test is still ahead
UCB's $2 billion Georgia biologics campus advances as drug demand rises, but manufacturing readiness and production timelines remain decisive.
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
Ono is paying Biohaven $80m before BHV-1300 has Phase 3 data. What exactly is it buying?
Biohaven gets $80 million upfront from Ono for Asian BHV-1300 rights as a 300-patient Phase 3 Graves’ disease trial tests the IgG degrader.
Features & Analysis
Pfizer TUKYSA gains FDA approval for first-line HER2-positive metastatic breast cancer maintenance
Pfizer’s TUKYSA gained first-line HER2-positive breast cancer maintenance approval after extending median PFS by 8.6 months.